Dorneyville Pharmacy — FDA 483 Findings

Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.

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

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

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

Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices and written procedures required by current good manufacturing practice regulations.

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.

Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.

Each lot of drug product containers and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.

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

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

Approved drug product containers and closures are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.

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

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