PharMEDium Services, LLC. — FDA 483 Findings

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

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.

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

There are no written procedures for production and process controls designed to assure that the drug products have the ident ity, strength, quality, and purity they purport or ar e represented to possess.

The labels and containers of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) and (B).

I There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

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

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.