An inspection at KRS Global Biotechnology’s facility in Boca Raton, Florida in March found “significant cGMP violations” causing drug products to be adulterated, the US Food and Drug Administration (FDA) said in the first letter published this week.
“The FDA investigator noted that drug products compounded in your facility that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health,” the agency noted. “For example, the investigator observed that operators were manually stoppering vials with their gloved hands.”
The firm also failed to establish written procedures designed to prevent microbiological contamination of sterile drugs, and an adequate system for monitoring environmental conditions in aseptic processing areas.
The FDA further pulled KRS up on its facility design, which fails to have adequate separation or defined areas to avoid product mix-ups.
Similarly, the FDA pulled up Little Rock, Arkansas-based SCA Pharmaceuticals for failing to establish adequate environmental monitoring systems and failing to thoroughly investigate unexplained discrepancies and batch failures, following an inspection also in March.
“The investigators observed that your firm failed to perform adequate investigations of sterility failures, batches found to contain particulates, and daily pressure differentials that were out-of-specification,” the letter said.
“Investigators also observed that your firm does not perform adequate environmental monitoring of the ISO 5 areas or endotoxin testing on all your sterile drug products.”
Both companies hit are registered with the FDA as outsourcing facilities, following recent changes in the law.
The Drug Quality and Security Act (DQSA) came into law in November 2013 updating the Federal Food, Drug, and Cosmetic Act (FDCA) and giving compounders the option to register as such a facility.
The update was deemed necessary following a deadly meningitis outbreak in 2012, traced to contaminated methylprednisolone made by the New England Compounding Center (NECC), in Massachusetts.
In February, the FDA published draft guidance to help compounders register as outsourcing facilities.