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Specialty Compounding Received “483” Warning Letter from FDA

Specialty Compounding Received “483” Warning Letter from FDA

August 14, 2013 — In March 2013, the U.S. Food and Drug Administration (FDA) issued a “483” Warning Letter (PDF) to Specialty Compounding, LLC, a compounding pharmacy located in Cedar Park, Texas. Although the FDA found many problems, they did not require Specialty Compounding to stop production. Nearly five months later, 15 people developed bacterial blood infections after receiving contaminated calcium injections.

Inspectors from the FDA visited Specialty Compounding on March 18-22, 2013 and documented numerous violations to good sterility practices.

On the first day, inspectors watched an employee wipe her forehead and another employee kneel on the floor to retrieve a fallen vial — all while wearing gloves that were not changed before the employees continued to work with sterile medicines.

The inspectors also found evidence of microbial growth in samples taken in “clean rooms” where sterile medicines were prepared. The inspectors found failures to test for sterility and endotoxins in injectable drug products. They also found that Specialty Compounding did not test products for the correct potency prior to release.

A review of testing logs also showed alerts about contaminated floors and surfaces, but no evidence of any investigation or corrective action to sterilize these areas.

“483” Warning Letters are used by the FDA to document problems observed during inspections. Although a response is not mandatory, recipients are encouraged to respond within 15 days to address each item and provide a timeline for correction. If serious problems are not corrected, the FDA can issue a Warning Letter, which can lead to enforcement action.

Do I have a Compounding Pharmacy Lawsuit?

The Schmidt Firm, PLLC is currently accepting compounding pharmacy induced injury cases in all 50 states. If you or somebody you know has been injured by a bacterial blood infection caused by Specialty Pharmacy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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