Techni Med, Inc. dba The Compounder — FDA 483 Findings

Protective apparel is not worn as necessary to protect drug products from contamination.

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.

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.

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

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.

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

Producer of Ster ile and Non- Steri l e Dr uq Products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.

Each lot of a component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.

There is no written testing program designed to assess the stability characteristics of drug products.