1Equipment and facility
Equipment and utensils are not sanitized at appropriate intervals to preve11t contamination that would alter tl1e safety, identity, strength, quality or purity ofthe drug product.
Inspection Record
University Pharmacy, Inc. — FDA 483 Findings
Inspectors Erika V. Butler · Zachery L. MillerThe inspectors who signed the published document.Inspector lookup
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 do not include adequate validation ofthe sterilization process.
3Stability and storage
Results of stability testing are not used in determining expiration dates.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
5Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
6Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory confomance to the final specifications and identity and strength of each 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.
