Specialty Compounding Received “483” Warning Letter from FDA

August 14, 2013 — Specialty Compounding, LLC, a compounding pharmacy based in Cedar Park, Texas, received a “483” Warning Letter (PDF) from the U.S. Food and Drug Administration (FDA) in March 2013. Five months later, an outbreak of bacterial blood infections that injured 15 people was linked to contaminated calcium gluconate injections compounded by the pharmacy.

The FDA became aware of serious problems at Specialty Compounding when inspectors visited the facility on March 18-22, 2013. The inspectors documented numerous violations of sterile drug practices, including employees wiping their foreheads and kneeling on the floor to retrieve fallen vials, while wearing gloves that were not changed before the employees continued working with medicines.

The inspectors found samples that tested positive for microbial growth in “clean rooms” where medicines were prepared, including areas where sterile drugs were prepared.

The inspectors also found that Specialty Compounding did not conduct routine sterility or endotoxin testing for all injectable drug products. They also failed to check that the medication had the proper potency prior to it being shipped out. A review of the logs showed that there were numerous alerts about contaminated surfaces and floors, with no documentation of any investigation or corrective action.

Despite evidence of questionable sterility practices, the FDA did not require Specialty Compounding to halt production.

The “483” Warning Letter lists observations from FDA representatives during an inspection. Recipients are strongly encouraged to respond within 15 days with a response that addresses each item and provide a timeline for correction or request for clarification. Although response is not mandatory, it can help a company avoid receiving a Warning Letter that can lead to enforcement action.

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