cGMPs / Compliance Management / Small Molecule

API Maker VUAB Pharma Receives FDA Warning Letter

Jun 03, 2015

Regulatory Affairs Professionals Society

VUAB Pharma of Roztoky, Czech Republic, was issued a Warning Letter by FDA on May 27, 2015, following an inspection of the facility by the FDA that found "significant deviations from current good manufacturing practice (CGMP)."

According to an article from RAPS, the FDA said it found a customer complaint indicating that a product was contaminated with Clostridium spehnoides. FDA reported subsequent testing by VUAB that was supposed to confirm the presence of the bacteria was insufficient to confirm the presence of the bacteria in the returned samples.

"Your test method was inadequate to detect Clostridium sphenoides growth," according to the FDA letter. "Once you modified the test method per your customer’s recommendation, your firm confirmed Clostridium sphenoides contamination in your retain sample."

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