PharMEDium Services, LLC — FDA 483 Findings

Equipment used in the manufacture, processing, packing or holding ofdrug products is not suitably located to facilitate operations for its intended use.

Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

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

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

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

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

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

Buildings used in the processing ofadrug product are not maintained in a good state ofrepair.

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

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

Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination ofthe drug product.

Containers and closures are not tested for' conformance with aU appropriate written propedures.

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