Inspection Record
View the regulator's official source The source document is always the basis for judgement.
Disinfecting agents, cleaning pads, and cleaning wipes used for sterile drug production were not always sterile or controlled in a manner as to maintain sterility.D isinfecting agents, cleaning pads, and cleaning wipes used for sterile drug production were not always sterile or controlled in a manner as to maintain sterility.
Your facility design allows the influx of poor quality into a higher classified area.
Poor aseptic practices were observed.
Media fills were not performed under the most challenging or stressful conditions.
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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