DEA probes Walgreens pharmacies over drug diversion in Florida

(Reuters) – The U.S. Drug Enforcement Administration is probing three Walgreen Co pharmacies in Florida in connection with a wide-ranging investigation of the diversion of prescription drugs for illicit use.

The Miami Field Division of the DEA issued the pharmacies with orders to show cause – notifications that are given to facilities requiring them to prove why they should be allowed to keep their licenses.

The pharmacies affected are Walgreens #04727 in Fort Pierce; Walgreens #03629 in Hudson; and Walgreens #06997 in Oviedo.

The actions by the DEA do not immediately prevent the pharmacies from handling or distributing potentially addictive controlled substances such as sedatives and narcotic pain-killers.

However, Special Agent in Charge Mark R. Trouville, of the DEA’s Miami Field Division, said the diversion of prescription drugs continues to be a “great concern for the DEA.”

A spokesman for Walgreens, Jim Graham, said the company stopped accepting prescriptions for certain controlled substances at these pharmacies last May in a bid to show its willingness to work with the DEA.

“We have taken a number of steps since mid-2011 to enhance our monitoring and reporting criteria,” he said in an e-mail. “These actions have resulted in a 35 percent drop in the number of tablets dispensed by our pharmacies in Florida for the most commonly abused pain management drug between June 2011 and March 2012.”

The pharmacy’s actions have included enhancing its ordering and inventory reporting requirements to limit quantities of several controlled substances with high risk potential, Graham said.

In April the DEA said it would inspect six Walgreens pharmacies and its Florida distribution center after the agency noticed a jump in purchases of the painkiller oxycodone. On September 14, the distribution center’s registration was suspended. An administrative hearing is scheduled to begin on that matter on January 7, 2013.

The DEA has been ratcheting up its focus on drug wholesalers and pharmacies over the past year as attempts to battle what the Centers for Disease Control and Prevention calls a prescription drug abuse epidemic. Deaths from narcotic pain-killers now exceed those of heroin and cocaine combined.

Florida has long been considered the epicenter of prescription drug abuse and the DEA has dismantled dozens of “pill mills” – sham pain clinics whose doctors write prescriptions for thousands of pain pills to drug dealers and addicts.

The DEA said the pharmacies who received the orders may file a written request with the agency within 30 days for an opportunity to have an administrative hearing to determine whether their right to sell controlled substances should be revoked.

(Reporting by Toni Clarke; Editing by Andrew Hay and Dan Grebler)

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France Veers to Left With Threat to Nationalize a Mill

France’s threat to nationalize a steel mill to prevent job losses is shaping up as a public relations disaster for the government—with potential collateral damage to the European steel industry as well.

President François Hollande’s Socialist government says it may take temporary control of the Hayange-Florange plant in Lorraine to prevent its owner, ArcelorMittal (MT), from eliminating about 630 of 2,700 jobs at the site. Industry Minister Arnaud Montebourg told Parliament on Nov. 28 that the government had already found a potential buyer for the facility, which ArcelorMittal does not want to sell. The transaction would involve “a temporary nationalization” and resale, Montebourg said.

Talks between the government and the steelmaker are continuing after a Nov. 27 tête-à-tête between Hollande and Chief Executive Lakshmi Mittal at the Elysée Palace failed to produce an agreement.

The showdown has sparked an uproar extending well beyond France’s borders. In a Nov. 26 newspaper interview, Montebourg said, “We don’t want Mittal in France,” and accused the company of breaking earlier promises to protect jobs. Lakshmi Mittal’s family told Le Monde it was “extremely shocked” by the comment. London Mayor Boris Johnson, who happened to be visiting Mittal’s native India at the time, told a group of Indian businessmen: “If France doesn’t want you, Britain does.”

Nationalization of private companies was abandoned decades ago by most major economies—including France, where it was last used by Socialist President François Mitterrand in the early 1980s.  Its resurrection, along with the government’s attacks on Mittal, aren’t likely to help French efforts to reverse a slump in foreign investment. According to the United Nations, foreign direct investment in France last year totaled $ 40.9 billion, less than half the figure five years ago. Even the left-leaning Paris newspaper Libération wondered in a Nov. 27 article whether nationalization was “really a good idea, or mission impossible?”

Underlying the Florange dispute is a big problem facing European steelmakers: Too much production capacity is chasing too few customers. Producers such as Luxembourg-based ArcelorMittal and Germany’s ThyssenKrupp (TKA:GR) collectively sell about 150 million tons of steel per year, utilizing only 71 percent of their capacity, says Seth Rosenfeld, an analyst at Jefferies International in London.

The excess capacity “reduces their pricing power” and weighs on profitability, Rosenfeld says. ArcelorMittal on Oct. 31 reported its lowest quarterly profit in almost three years.

With steel demand slumping almost everywhere in the world except China, other producers are struggling to cut capacity. ThyssenKrupp is trying to sell mills in the U.S. and Brazil, and Russia’s Novolipetsk Steel wants to downsize its mill at Louvière, Belgium.

Against that backdrop, transferring ownership of Florange to another company “continues the situation of having excess steelmaking capacity,” Rosenfeld says. “The government has a short-term view toward job preservation, rather than a longer-term view toward allowing the steel industry to remain profitable.”

ArcelorMittal wants to close two blast furnaces at Florange that are already idle, while continuing to operate other factories at the site. Taking those factories away from ArcelorMittal would disrupt its supply chain, jeopardizing “substantially more jobs” among the 20,000 the company employs in France, says Charles Bradford, an independent steel industry analyst in New York. “Arcelor has an integrated setup, some plants feed other plants,” he says. Without supplies from Florange, “other mills would have to close because they wouldn’t have the feedstock.”

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X Factor judge Louis Walsh settles defamation case

DUBLIN (Reuters) – Television personality and pop music producer Louis Walsh on Wednesday settled a 500,000 euro ($ 640,000) defamation case against News Group Newspapers in Ireland.

The deal came after Walsh, best known for his role as a judge on the hit television show “The X Factor”, sued the group for publishing a story last year based on false allegations that he had groped a man in a Dublin night club.

Leonard Watters, who made the accusations before later retracting them, was jailed for six months earlier this year.

Paul Tweed, Walsh’s solicitor, said: “The publishers of the Irish, UK and online editions of the Sun have this morning unreservedly apologized to Louis Walsh.

“They have also agreed to pay very substantial damages of 500,000 euros together with his legal costs.”

Walsh, who managed Irish boy bands Westlife and Boyzone, said the story had a “terrible effect” on him.

“I’m very satisfied with this morning’s total vindication for me, but I remain very angry at the treatment I received at the hands of the Sun,” he said outside court.

“I have the utmost respect and time for most journalists with whom I’ve always enjoyed a good relationship, and I’m therefore absolutely gutted and traumatized that these allegations should have been published

“I wouldn’t wish this on my worst enemy.”

The Sun said it apologized “unreservedly”.

(Reporting by Sarah O’Connor)

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US rabbi says jailed American in good health

HAVANA (AP) — A prominent New York rabbi and physician visited an American subcontractor serving a long jail term in Cuba and said the man is in good health, despite his family’s concerns about a growth on his right shoulder.

Rabbi Elie Abadie, who is also a gastroenterologist, told The Associated Press in an exclusive interview following Tuesday’s 2 1/2-hour visit at a military hospital in Havana that he personally examined Alan Gross and received a lengthy briefing from a team of Cuban physicians who have attended him.

He said the 1 1/2-inch growth on Gross’s shoulder appeared to be a non-cancerous hematoma that should clear up by itself.

“Alan Gross does not have any cancerous growth at this time, at least based on the studies I was shown and based on the examination, and I think he understands that also,” Abadie said.

Abadie said the hematoma, basically internal bleeding linked to the rupture of muscle fiber, was likely caused by exercise Gross does in jail. He said the growth ought to eventually disappear on its own.

Gross’s plight has put already chilly relations between Cuba and the United States in a deep freeze. The Maryland native was arrested in December 2009 while on a USAID-funded democracy building program and later sentenced to 15 years in jail for crimes against the state.

He claims he was only trying to help the island’s small Jewish community gain Internet access.

Gross’s health has been an ongoing issue during his incarceration. The 63-year-old, who was obese when arrested, has lost more than 100 pounds while in jail.

Abadie, a rabbi at New York’s Edmund J. Safra Synagogue, said Gross’s weight is appropriate for a man his age and height.

Photos that Abadie and a colleague provided to AP of Tuesday’s meeting with Gross showed him looking thin, but generally appearing to be in good spirits.

In one photo, Gross holds up a handwritten note that says “Hi Mom.”

“He definitely feels strong. He is in good spirits. He feels fit, to quote him, physically. But of course, like any other person who is incarcerated or in prison, he wants to be free. He wants to be able to go back home,” Abadie said.

Gross’s family has repeatedly appealed for his release on humanitarian grounds, noting his health problems and the fact that his adult daughter and elderly mother have both been battling cancer.

Jared Genser, counsel to Alan Gross, said late Tuesday that Rabbi Abadie is not Gross’s physician and he would like an oncologist of his choosing to evaluate him.

“While we are grateful Rabbi Abadie was able to see Alan, we have asked an oncologist to review the test results to determine if they are sufficient to rule out cancer. More importantly, if Alan is so healthy, we cannot understand why the Cuban government has repeatedly denied him an independent medical examination by a doctor of his choosing as is required by international law,” said Genser.

Gross and his wife recently filed a $ 60 million lawsuit against his former Maryland employer and the U.S. government, saying they didn’t adequately train him or disclose risks he was undertaking by doing development work on the Communist-run island.

They filed another lawsuit against an insurance company they say has reneged on commitments to pay compensation in case of his wrongful detention.

Separately, a lawyer for Gross has written the United Nations’ anti-torture expert, saying Cuban officials’ treatment of his client “will surely amount to torture” if he continues to be denied medical care.

Rumors have been swirling in U.S. media that Cuba might soon release Gross as a gesture of good will or in the hopes of winning concessions from the administration of President Barack Obama, but Abadie said that those reports appeared to be false.

“As far as I know there is no truth to it,” he said.

Abadie said he met with senior Cuban officials who expressed their desire to resolve the case “as quickly as possible,” but would not say specifically who he spoke with or what they offered.

“They claim that they are more than willing to sit at the table,” he said.

Cuban officials have strongly implied they hope to trade Gross for five Cuban agents sentenced to long jail terms in the United States, one of whom is already free on bail.

Abadie said Gross made clear that he does not want his case linked to that of the agents, known in Cuba as “The Five Heroes,” because he does not believe he is guilty of espionage.

But Abadie said Gross is hoping for a “constructive and productive” dialogue between U.S. and Cuban officials to resolve his case.

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Exclusive: Banks offer to help Sony offload battery unit – sources

TOKYO (Reuters) – Sony Corp has been approached by at least three investment banks offering to sell its battery business as the struggling Japanese group looks to offload non-core assets and focus on reviving its consumer electronics business, banking sources said.

Selling the unit, which employs 2,700 people and had sales last year of $ 1.74 billion, would help Sony cut costs and generate cash as it restructures its operations, three people involved in the preliminary discussions told Reuters.

The company, a byword for innovative gadgetry in the 1970s and 80s, has been battered by weak demand for its TVs in a fiercely competitive market. The TV business has racked up huge losses; Sony’s market value has slumped to below $ 10 billion and ratings agency Fitch last week downgraded the company’s debt to “junk” status – a move likely to push up borrowing costs and make asset sales more attractive.

CEO Kazuo Hirai has pledged to rebuild Sony around gaming, digital imaging and mobile devices, while nurturing new businesses such as medical devices. He is axing 10,000 jobs, closing facilities and selling assets. Any disposals would be part of a broader “garage sale” by Japan’s leading electronics groups that are hurting in weak markets and tight financing.

Potential buyers for Sony Energy Devices Corp – founded in 1975 as Sony-Eveready, a joint venture with Union Carbide Corp – could include Taiwan’s Hon Hai Precision Industry and BYD Co Ltd, a Chinese carmaker backed by billionaire investor Warren Buffett, said one of the sources. Hon Hai is also in negotiations to become rival TV maker Sharp Corp’s biggest shareholder.

FOREIGN INTEREST

Despite a strong yen, interest is likely to come mainly from potential foreign buyers, said the sources, who did not want to be named as the talks are private.

Selling the business overseas may not go down well with a Japanese government that in the past has kept technology at home by promoting alliances between local producers. Panasonic Corp, NEC Corp and Hitachi Ltd also make lithium-ion batteries, though the firms’ fabrication technology differs.

Sony declined to comment on the possible sale of the business, which makes lithium-ion batteries used in smartphones, tablets and PCs. “At our corporate strategy announcement in April, (Hirai) said we would explore possible alliances in E-vehicle batteries and battery storage,” said spokesman George Boyd.

As with TVs, Sony has struggled to compete against South Korean rivals in a battery business that is worth $ 18 billion a year. The small cells that power mobile devices now account for around 60 percent of the market, ahead of those used in cars and electrical tools, according to research company IHS iSuppli.

While lithium-ion battery demand has steadily expanded with the boom in mobile consumer electronics, severe price competition has resulted in razor thin margins that favor large-scale manufacturers with weak local currencies.

“The battery business is a prime example of the company’s loss-making and unwanted assets. It doesn’t make sense for them to keep it,” said one of the banking sources.

FALLING MARKET SHARE

As Hirai doubles down on Sony’s strength in consumer electronics, the company has sold a chemicals company, with 2,900 workers, and may also let go its U.S. headquarters building in New York go. At the same time, it has spent close to $ 2 billion on a U.S. game clouding company and a stake in medical equipment maker Olympus Corp.

Sony produced 74 million lithium-ion battery cells in July-September – almost 40 percent fewer than in the first quarter of 2008, when its output topped Samsung SDI Co Ltd’s 110 million and LG Chem Ltd’s 54 million, according to Techno System Research in Tokyo. Sony’s market share is now 7 percent, dwarfed by Samsung SDI’s 27 percent, Panasonic’s 21 percent and LG Chem’s 17 percent.

Sony’s battery unit, which also makes button batteries for watches and smaller appliances and optical devices, has three factories in Japan and two overseas assembly plants in China and Singapore. It has yet to enter the more lucrative business for automotive batteries.

In its most recent filing, Sony valued the battery unit’s fixed assets, including production sites and machinery, at 52 billion yen ($ 633 million). Under Sony’s accounting rules, asset sales are typically booked as operating profit.

The cost to protect $ 10 million of Sony debt against default for five years has edged higher this week to almost $ 400,000. The CDS spreads had tumbled earlier this month – from above 480 basis points – after Sony said it would raise 150 billion yen ($ 1.9 billion) through a sale of convertible bonds.

($ 1 = 82.1200 Japanese yen)

(Additional reporting by Reiji Murai; Editing by Ian Geoghegan)

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Salary growth lagging for primary care doctors

NEW YORK (Reuters Health) – Despite rising spending on health care in the United States, primary care doctors don’t seem to be reaping the rewards on their paychecks, a new study suggests.

The findings could have implications for what some predictions say will be a primary care shortage in some parts of the country in the coming years.

Researchers found that since the late 1980s, the average doctor‘s earnings have grown more slowly than the salaries of other health professionals, such as pharmacists, dentists and registered nurses.

“It is possible that there are some specialties that have done extremely well in the past 10 or 15 years,” said health policy researcher Amitabh Chandra from Harvard University in Cambridge, Massachusetts, who worked on the study.

But, “In terms of the experience of the median doctor, the median doctor is not at the heart of all the cost growth we’re seeing in America.” And that may have implications for the primary care field in the future, he noted.

For their study, Chandra and his colleagues analyzed data from a nationally-representative survey of Americans’ occupations and earnings conducted every year between 1987 and 2010. Each round included people older than 35 from 60,000 different households.

Over the 14-year study, 30,556 health professionals were surveyed, including 6,258 doctors.

The researchers found that between 1987-1990 and 2006-2010, the median doctor’s annual earnings grew from $ 143,963 to $ 157,751 – a difference of 9.6 percent. That was after taking into account any salary differences based on gender, age and location.

In comparison, the average pharmacist’s earnings increased by 44 percent, from $ 70,341 to $ 101,279, and the average dentist’s by 23 percent, from $ 105,511 to $ 129,795, the researchers reported Tuesday in the Journal of the American Medical Association.

Looking closer, the study team found that doctors’ salaries grew between 1987-1990 and 1996-2000, but then were stagnant over the next decade – a time when other health professionals continued to get bigger paychecks.

Because the earnings reflect pay for doctors in the middle of the salary pack, Chandra said the slow growth probably represents patterns for primary care doctors rather than specialists – and earnings for some “procedure-driven specialties,” such as cardiology, may have grown a lot.

Medicare payment cuts, as well as tougher bargaining by insurance companies, may be partly to blame for the “sluggish” growth in the primary care field, he added.

THE WHOLE PACKAGE?

In addition, more women and minorities are becoming doctors – and research has suggested they make less money than white, male physicians, said Bob Konrad from the University of North Carolina at Chapel Hill, who has studied doctor salaries.

He said the new findings may also not tell the whole economic story for primary care doctors.

Recently employers have started offering to pay off more of new doctors’ college and medical school debt as a way of luring top candidates, he said – but such financial benefits wouldn’t show up on their paychecks.

“Going forward, thinking about physician incomes, you have to think about the whole package,” Konrad, who wasn’t involved in the new study, told Reuters Health.

But Chandra said the study may have implications for some parts of the U.S. that are already facing a shortage of primary care doctors.

“If as a country we want more people to go into primary care, this anemic, jaundiced earnings growth is not going to be a motivator to get people to join primary care,” he told Reuters Health.

One profession not covered by the new research, Konrad pointed out, is wage workers such as home health aides.

“That’s a big part of the healthcare workforce and growing much faster than many other occupations,” he said. What’s more, “The hourly wage of a home health aide has been going down every year for the last 10 years… Half the people in the health sector are in the bottom half (of American workers) – they’re making less than $ 40,000 a year.”

SOURCE: http://bit.ly/JjFzqx Journal of the American Medical Association, online November 27, 2012.

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Oil below $87 after OECD cuts growth forecasts

BANGKOK (AP) — The price of oil fell below $ 87 a barrel Wednesday after the Organization for Economic Cooperation and Development cut its growth outlook for the U.S. and the 17 countries that use the euro currency.

Benchmark oil for January delivery was down 23 cents to $ 86.96 per barrel at late afternoon Bangkok time in electronic trading on the New York Mercantile Exchange. The contract fell 56 cents to finish at $ 87.18 a barrel on the Nymex on Tuesday.

The Paris-based OECD said Tuesday that the combined economy of the 17 euro countries will contract by 0.4 percent this year, worse than May’s 0.1 percent forecast. For 2013, it will contract a further 0.1 percent.

The OECD also downgraded its forecasts for the U.S. economy. Even if the White House and Congress strike a budget deal before Jan. 1 and avoid the so-called fiscal cliff of automatic tax hikes and spending cuts, the OECD said the U.S. will grow by only 2 percent next year, down from May’s forecast of 2.6 percent.

Traders said weak economic growth would likely hurt demand for energy.

Michael Hewson, senior market analyst of CMC Markets, said the OECD report refocused concerns on “the toxic effect the European crisis continues to have on global growth prospects.”

Brent crude, which is used to set prices for many international varieties of oil, fell 28 cents to $ 109.59 a barrel on London’s ICE Futures exchange.

In other energy futures trading on the Nymex:

— Wholesale gasoline was down 0.3 cent at $ 2.692.

— Natural gas fell 2 cents to $ 3.749 per 1,000 cubic feet.

— Heating oil fell 0.2 cent to $ 3.023 a gallon.

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Follow Pamela Sampson on Twitter at http://twitter.com/pamelasampson

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Mexican beauty queen killed in shootout

CULIACAN, Mexico (AP) — A 20-year-old state beauty queen died in a gun battle between soldiers and the alleged gang of drug traffickers she was traveling with in a scene befitting the hit movie “Miss Bala,” or “Miss Bullet,” about Mexico’s not uncommon ties between narcos and beautiful pageant contestants.

The body of Maria Susana Flores Gamez was found Saturday lying near an assault rifle on a rural road in a mountainous area of the drug-plagued state of Sinaloa, the chief state prosecutor said Monday. It was unclear if she had used the weapon.

“She was with the gang of criminals, but we cannot say whether she participated in the shootout,” state prosecutor Marco Antonio Higuera said. “That’s what we’re going to have to investigate.”

The slender, 5-foot-7-inch brunette was voted the 2012 Woman of Sinaloa in a beauty pageant in February. In June, the model competed with other seven contestants for the more prestigious state beauty contest, Our Beauty Sinaloa, but didn’t win. The Our Beauty state winners compete for the Miss Mexico title, whose holder represents the country in the international Miss Universe.

Higuera said Flores Gamez was traveling in one of the vehicles that engaged soldiers in an hours-long chase and running gun battle on Saturday near her native city of Guamuchil in the state of Sinaloa, home to Mexico’s most powerful drug cartel. Higuera said two other members of the drug gang were killed and four were detained.

The shootout began when the gunmen opened fire on a Mexican army patrol. Soldiers gave chase and cornered the gang at a safe house in the town of Mocorito. The other men escaped, and the gunbattle continued along a nearby roadway, where the gang’s vehicles were eventually stopped. Six vehicles, drugs and weapons were seized following the confrontation.

It was at least the third instance in which a beauty queen or pageant contestants have been linked to Mexico’s violent drug gangs, a theme so common it was the subject of a critically acclaimed 2011 movie.

In “Miss Bala,” Mexico’s official submission to the Best Foreign Language Film category of this year’s Academy Awards, a young woman competing for Miss Baja California becomes an unwilling participant in a drug-running ring, finally getting arrested for deeds she was forced into performing.

In real life, former Miss Sinaloa Laura Zuniga was stripped of her 2008 crown in the Hispanoamerican Queen pageant after she was detained on suspicion of drug and weapons violations. She was later released without charges.

Zuniga was detained in western Mexico in late 2010 along with seven men, some of them suspected drug traffickers. Authorities found a large stash of weapons, ammunition and $ 53,300 with them inside a vehicle.

In 2011, a Colombian former model and pageant contestant was detained along with Jose Jorge Balderas, an accused drug trafficker and suspect in the 2010 bar shooting of Salvador Cabanas, a former star for Paraguay‘s national football team and Mexico’s Club America. She was also later released.

Higuera said Flores Gamez’s body has been turned over to relatives for burial.

“This is a sad situation,” Higuera told a local radio station. She had been enrolled in media courses at a local university, and had been modeling and in pageants since at least 2009.

Javier Valdez, the author of a 2009 book about narco ties to beauty pageants entitled “Miss Narco,” said “this is a recurrent story.”

“There is a relationship, sometimes pleasant and sometimes tragic, between organized crime and the beauty queens, the pageants, the beauty industry itself,” Valdez said.

“It is a question of privilege, power, money, but also a question of need,” said Valdez. “For a lot of these young women, it is easy to get involved with organized crime, in a country that doesn’t offer many opportunities for young people.”

Sometimes drug traffickers seek out beauty queens, but sometimes the models themselves look for narco boyfriends, Valdez said.

“I once wrote about a girl I knew of who was desperate to get a narco boyfriend,” he said. “She practically took out a classified ad saying ‘Looking for a Narco’.”

The stories seldom end well. In the best of cases, a beautiful woman with a tear-stained face is marched before the press in handcuffs. In the worst of cases, they simply disappear.

“They are disposable objects, the lowest link in the chain of criminal organizations, the young men recruited as gunmen and the pretty young women who are tossed away in two or three years, or are turned into police or killed,” Valdez said.

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Associated Press Writer E. Eduardo Castillo contributed to this report

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HTC confirms 5-inch ‘Deluxe’ smartphone won’t launch in Europe

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Outbreak-Tied Peanut Butter Plant Shut

Nov 26, 2012 7:37pm

The Food and Drug Administration today shut down the country’s largest organic peanut butter processor following a salmonella outbreak that sickened scores of people nationwide.

For the first time the FDA has utilized new power granted by the 2011 food safety law and shut down Sunland Inc.’s New Mexico processing plant.

In a statement on their website, the FDA said that the link between the company and the salmonella outbreak that sickened 41 people in 20 states along with “Sunland’s history of violations led FDA to make the decision to suspend the company’s registration.”

Between June 2000 and September 2012 eleven product lots of nut butter tested positive for presence of Salmonella. And, according to the FDA, between March 2010 and September 2012, Sunland Inc. distributed at least a portion of eight product lots after they had tested positive.

The FDA also found the presence of Salmonella in 28 environmental samples during a September and October 2012 inspection.  FDA inspectors reported that employees of Sunland Inc. failed to wash hands, improperly handled equipment used to process food as well as providing  ”no records” to document cleaning of equipment. Additionally, the building housing the production and packaging had no hand-washing sinks even though employees had “bare-handed contact” with the product.

“The super-sized bags used by the firm to store peanuts were not cleaned despite being used for both raw and roasted peanuts.  There was a leaking sink in a washroom which resulted in water accumulating on the floor, and the plant is not built to allow floors, walls and ceilings to be adequately cleaned.

Finally, investigators found that raw materials were exposed to potential contamination.  Raw, in-shell peanuts were found outside the plant in uncovered trailers. Birds were observed landing in the trailers and the peanuts were exposed to rain, which provides a growth environment for Salmonella and other bacteria.  Inside the warehouse, facility doors were open to the outside, which could allow pests to enter.”

In a November 15 statement the president and CEO of Sunland, Jimmie Shearer, emphasized that at “no time” did the company distribute products they knew to be contaminated. The company has submitted a response to the FDA outlining their response to the recall and contaminated product testing.

“We believe that drawing any inferences much less conclusions about the Company’s practices based solely on the observations as set forth in the Form 483 without considering the Company’s response would be wholly premature and unduly prejudicial to Sunland.”

Food Safety Modernization Act, which the FDA acted under to shut down the plant, grants the agency the authority to suspend manufacturing when there is “reasonable probability of causing serious adverse health consequences or death to humans or animals, and other conditions are met.”

Sunland Inc., can request an informal hearing to lift the suspension.  However the 24-year-old company will only have its registration returned after the FDA decides the company has safe manufacturing practices.

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