Stonegate Pharmacy LP — FDA 483 Findings

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

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

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 ofeach active ingredient prior to release.

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

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

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

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

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.

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

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

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.