FDA 483 - FMKLABS - March 08, 2019

BKCLASS, a manufacturer in Corona, CA, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to ensure adequate employee training, follow written procedures for component approval, and maintain complete batch production records. Additionally, the inspection revealed a lack of investigations for unexplained discrepancies, absence of annual product reviews for OTC products, and insufficient equipment qualification and cleaning validation.