Inspection Record
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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.
Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
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