FDA 483 - Dorneyville Pharmacy - January 07, 2016

This FDA Form 483 details numerous deficiencies observed during an inspection. The facility failed to withhold drug product containers and closures from use until quality control release, as evidenced by the use of vials from a failed sterilization indicator lot. Procedures to prevent microbiological contamination of sterile drug products were not established or followed, specifically regarding the dispensing of a component in the ISO 7 Ante Room and its transfer to the ISO 5 laminar flow hood.

Personnel clothing was inappropriate; an employee entered the ISO 7 Ante Room without proper handwashing, hair net, gown, or sterile gloves, and improperly handled face masks and shoe covers. Gowns and gowning components for ISO 5 areas were not sterile, stored exposed to uncontrolled environments, and operators had exposed skin. Gowning processes were not standardized, and there was no evidence to support the sanitization of used gowns.

No written testing program for drug product stability was established, lacking procedures for sterility, potency, and endotoxin levels over shelf life. Sterilization processes for drug products made from non-sterile components were not validated, and shelf life of a redacted component was not supported by testing. Potency testing of drug products prior to release was not conducted.

The environmental monitoring program was inadequate, with infrequent air, personnel glove, and surface sampling. Approved containers and closures lacked expiration dating, and product contact equipment lacked beyond-use dates. Sterilization documentation for equipment, containers, and closures was absent.

Drug product production and control records were