Inspection Record
View the regulator's official source The source document is always the basis for judgement.
Your media fills are not representative of your firm's routine aseptic processing practices and do not incorporate appropriate worst-case activities and conditions that challenge your aseptic operations.
Your firm did not perform appropriate environmental monitoring in your aseptic processing areas.
Biological indicators are not used to verify the adequacy of the sterilization cycle of <Redacted B4> to sterilize your firm's glassware used in sterile operations.
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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