1Contamination control
There was a failure to handle and store closures at all times in a manner to prevent contamination.
Inspection Record
Genentech Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not followed.
3Deviation, CAPA, and investigation
Written records ofinvestigations into unexplained discrepancies and the failure ofa batch or any ofits componen~ to meet specifications do not include the conclusions and follow-up.
4Equipment and facility
Equipment used in the manufacture, processing, packing or holding ofdrug products is not ofappropriate design to facilitate operations for its intended use.
About this record
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.
