Inspection Record
View the regulator's official source The source document is always the basis for judgement.
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.
Non-microbial contamination was observed in your non-sterile drug production area.
Extracted automatically from the document US FDA published on 2021-10-05. 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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