1Training and personnel
Clothing of personnel engaged in the manufacturing of drug products is not appropriate for the duties they perform.
Inspection Record
PharMEDium Service, Inc. — FDA 483 Findings
Inspectors Stephen D. Brown · Scott T. BallardThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Reserve samples for drug products are not retained for one year after the expiration date of the drug product.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
4Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
5Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
6Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
7Laboratory and QC controls
The accuracy and sensitivity of test methods have not been established.
8Laboratory and QC controls
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.
9Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
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.
