FDA 483 - Novocol Pharmaceutical of Canada, Inc. - June 18, 2019

Novocol Pharmaceutical of Canada, Inc. was cited for three observations during an FDA inspection. The firm failed to follow established procedures for preventing microbiological contamination of sterile drug products, including visual inspection qualification and semi-automated inspection protocols. Additionally, the company did not properly document and evaluate recurring priority 1 alarms as required by its alarm response procedure.