PharMEDium Services LLC — 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.

Results of stability testing are not used in deter mining expiration dates .

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

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

Drug product containers or closures are reactive so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.

Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.