First Royal Care Co. LLC dba Red Mountain Compounding Pharmacy — FDA 483 Findings

Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed.

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

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.

Written procedmes for cleaning and maintenance fail to include assignment of responsibility, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assu...

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.

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.

Written records are not made of investigations into unexplained discrepancies.

Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

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

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