1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Inspection Record
Hugel, Inc. — FDA 483 Findings
Inspectors Yetao JinThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Your finn lacks an established cleaning and disinfection program to prevent the introduction ofmicrobial contaminationID including Clostridium botulinum spores and toxin, into controlled manufacturing environments in your Building<~: rug substance and drug product manufacturing facilities.
3Environmental monitoring
Your environmental monitoring program for the Buildint} drug substance manufacturing facility is deficient.
4Laboratory and QC controls
Laboratory records are deficient in that your firm has not established adequate procedural controls to ensure assay data traceability, reliability, and accuracy.
About this record
Extracted automatically from the document US FDA published on 2024-09-23. 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.
