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Pharmaceuticals / Inspections and Audits

FDA Hits API Manufacturer for Contamination Risks

Jan. 2, 2019
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The FDA handed BASF a Form 483 after finding that the drugmaker’s Quincy, Florida, facility put its API products at risk of contamination and failed to follow procedures for OOS results.

The agency investigator discovered issues with the drugmaker’s stability testing and API warehouse conditions during an Aug. 20 to 21 inspection.

Specifically, the investigator found what appeared to be a dead cockroach, grime and pellets in the warehouse next to packaged API product. There were also openings and gaps in the building’s exterior wall that were large enough to let in sunlight.

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