PharMEDium Services LLC — FDA 483 Findings

Certificates of testing of containers and closures are accepted in lieu of testing without establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.

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.

There was a failure to handle and store components at all times in a manner to prevent contamination.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.

The written stability program for drug products does not include meaningful and specific test methods.

Reserve drug product samples are not retained and stored under conditions consistent with product labeling.

The production area air supply lacks an appropriate air filtration system.

Written production and process control procedures are not followed in the execution of production and process control functions.

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

The quality control unit lacks authority to fully investigate errors that have occurred.

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

Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.