Stonegate Pharmacy LP — FDA 483 Findings

Routine calibration of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.

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

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

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

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

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

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

Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

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.

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