Lab That Made Tainted Drug In Meningitis Outbreak Was Filthy

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Posted on 27th October 2012 by gjohnson in Uncategorized

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When the Food and Drug Administration (FDA) inspected the pharmacy company that manufactured a contaminated medicine linked to 25 deaths, what it found would make your stomach turn.

Some 83 out of 321 vials contained “what appeared to be a greenish foreign matter,” the FDA said in an eight-page report late last week. Seventeen vials from that bin contained “what appeared to be white filamentous material.” One vial had a fungus.

There was bacteria and mold in a supposedly sterile room where drugs were made. And the air conditioner was put off at night, despite the fact that temperature and humidity were supposed to be carefully controlled at the facility.

http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM325980.pdf

The New York Times did a Page One story Saturday based on the FDA’s report , called a “483,” on its inspection of the New England Compounding Center (NECC) in Farmingham, Mass. This is the company that manufactured the tainted steroid, injected as a pain killer, that allegedly caused a national outbreak of  fungal meningitis. Two dozen are dead, more than 300 are sick and possibly 14,000 were exposed to the steroid, according to The Times.

http://www.nytimes.com/2012/10/27/health/fda-finds-unsanitary-conditions-at-new-england-compounding-center.html?pagewanted=all&_r=0

“The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass., facility,” the federal agency said in a press release.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm325994.htm

“The investigators also observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination,” the FDA said.

“Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container.”

Finally, the press release said, “The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations. The 483 does not constitute a final FDA determination that any observation listed on the 483 is a violation of the Federal Food, Drug, and Cosmetic Act or any related regulations.”

I think it’s a pretty safe bet that the FDA will ultimately there were violations by NECC, don’t you?

The FDA said it was continuing to work the U.S. Centers for Disease Control and Prevention and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak of fungal meningitis among patients who received NECC’s compounded preservative-free methylprednisolone acetate, an injectable steroid.

The problem with compounding centers such as NECC is that they have essentially not been regulated by the FDA, since they are not full-fledged drug makers. As The Times pointed out in its Saturday story about NECC, “Instead of producing tailor-made drugs for individual patients, as the law allowed, the company turned into a major drug maker that supplied some of the most prestigious hospitals in the country.”

The FDA report also noted that NECC “is abutted to the rear and along the left parking area by a recycling facility that handles such materials as mattresses and plastics … the area was observed to include large equipment (e.g. excavators and freight trucks) producing airborne particulates (e.g. dust). Rooftop units serving the firm’s HVAC system were estimated to be located approximately 100 feet from the recycling facility.”

What did some of the experts say about this mess?

A pharmaceutical sterility expert, Russell Madsen, when asked about the FDA’s inspection report told The Times, “In all my time in the pharmaceutical industry, which is 45 years, I’ve never seen one this bad.”

 

 

 


Attorney Gordon Johnson
Past Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

Banana Boat Spray-On Suntan Lotion Recalled After ‘Adverse Effects’

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Posted on 22nd October 2012 by gjohnson in Uncategorized

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Here’s a frightening scenario: You spray on some sun tan lotion, someone lights a cigarette near you and you ignite in flames.

That’s the potential danger that last Friday prompted the maker of Banana Boat Sun Care to voluntarily recall some its spray-on products from the market.

http://www.fda.gov/Safety/Recalls/ucm324824.htm

Energizer Holdings Inc., based in St. Louis, said it was withdrawing about two dozen spray-on Banana Boat sun care products, such as Continuous Mist and Ultra Mist, “due to a potential risk of product igniting on the skin if contact is made with a source of ignition before the product is completely dry.”

In its press release, the company said, “Energizer believes that this issue is associated with the product delivery system, specifically the size of the spray valve opening on the affected products. The spray valve opening on the affected products dispenses more than is typical in the industry for continuous sun care sprays. As a result, the product is taking longer to dry on the skin than is typical with other continuous sprays. If a consumer comes into contact with a flame or spark prior to complete drying of the product on the skin, there is a potential for the product to ignite.”

The company reported that it had “received four reports of adverse events involving burns associated with the use of the Banana Boat SPORT Ultramist SPF 30 and 50 products in the US, and one event in Canada.”

Five “adverse events”? I hope no one was burned to a crisp.

These over-the-counter products were distributed nationwide to wholesalers and retailers from January 2010 through Sept. 30.

Energizer said it was  notifying its retail partners to stop selling the product.

“Consumer safety is the primary objective of Energizer and therefore it has voluntarily initiated this market withdrawal,” the company said in its press release “As already described, Energizer believes it has identified the cause of this safety concern and expects to offer new Banana Boat continuous spray products shortly.”

Energizer then added this little caveat: “Consistent with existing warnings on all continuous spray sun care products, consumers should take care to avoid sources of ignition when using these products, should not smoke while using these products, and should not use these products in the presence of a flame or spark.”

Energizer advised anyone who purchased any of the various versions of spray-on Banana Boat that the company cited  not to use them.

Consumers with questions or complaints regarding the recall can contact Energizer by calling Consumer Affairs at 1-800-SAFESUN (1-800-723-3786) Monday through Friday, 8 a.m. to 7 p.m. Eastern Times, or by sending an email to: SUNCARE@customerfollowup.info.

The U.S. Food and Drug Administration is aware of the recall, according to Energizer.

So-called “adverse events” that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid FDA form 3500 available at:
    www.fda.gov/MedWatch/getforms.htm.
    Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
  • Fax: 1-800-FDA-0178

 

 

 

 

 

 

 


Attorney Gordon Johnson
Past Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.