1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include validation ofthe sterilization process.
Inspection Record
College Pharmacy Incorporated — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Each batch ofdrug product required to be free ofobjectionable microorganisms is not tested through appropriate laboratory testing.
3Material and supplier control
Each lot ofa component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
4Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
5Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing ofdrug products.
6Laboratory and QC controls
Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the final specifications and identity and strength ofeach active ingredient prior to release.
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.
