1Contamination control
Clostridium botulinum spore containment in the drug substance manufacturing areas is inade uate to miti ate spore cross contamination risk of other manufacturing areas.
Inspection Record
Hugel Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Environmental monitoring
Environmental monitoring is insufficient to ensure that the drng product manufacturing areas are not contaminated with Clostridium botulinum spores as Clostridium spores are not monitored as paii of environmental monitoring (A WLS-FE-039-29).
3Other quality system
Decontamination of Clostridium botulinum spores and toxin in the chug substance manufacturing areas is inadequate.
About this record
Extracted automatically from the document US FDA published on 2022-09-06. 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.
