Clinical Apothecaries — FDA 483 Findings

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Clothing of personnel engaged in the processing ofdrug products is not appropriate for the duties they perform.

There is no written testing program designed to assess the stability characteristics of drug products.

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropliate validation of the supplier's test results at appropriate intervals.

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation ofthe sterilization process.