Medistat RX L.L.C. — FDA 483 Findings

Routine calibration of equipment is not performed according to a written program designed to assure proper perfonnance.

Clothing of personnel engaged in the manufacturing, processing.

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

Each batch of drug product purporting lobe pyrogen-free is not laboratory tested to detemline c:onfonnance to such req uirements.

Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.

Aseptic processing areas are deficient regarding.

Written procedures describing the handling of COJl)plaints do not include provisions for review by the quality control unit of any complaint involvi ng the possible failure of a drug product to meet any of its specifications, a determ ination as to the need for an investigation of any u n~xplained discrepancy, and explaining the teasons for t he failure of the batch -or any of its components to meet specifications.

Testing and release of drug product for distribu tion do not ioclude appropr iate laboratory detcmlination ofsatisfactory conformance to the identity and st rength of each active ingredient prior to release.

Drug products failing to meet esta~lished specifications arc not rejected, Spcciftcally, you did not take C<lrrective action for two lots of Progeliterone capsules that failed potency and were distributed.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do n ot include validation of the sterilization process.