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 .
equipment materials and or supplies are not disinfected prior to entering the aseptic processing areas.
iso 5 classified areas were not certified under dynamic conditions speci fically a from 6/2/2017 to 7/19/2017 72 sterile drug products were mad e however certification of the following units expir ed on 06/2017: i.
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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