CFP Acquisitions, Inc — FDA 483 Findings

Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.

Pressure differentials between areas with different air classifications were not monitored prior or during sterile drug production.

Environmental monitoring samples were not performed to ensure recovery oforganisms.

Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection.

The ISO 5 classified aseptic processing areas bas difficult to clean or particle-generating equipment or surfaces.