Leiter's Cambrian Park Drugs, Inc. — FDA 483 Findings

Written procedures are lacking for the use of fumigating agents and cleaning and sanitizing agents designed to prevent the contamination of equipment, components, drug product containers, and drug products.

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.

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

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

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

Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision, and provisions for remedial action if limits are not met.

Protective apparel is not worn as necessary to protect drug products from contamination.

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

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

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.

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

The master production and control records are deficient in that they do not include a statement concerning any calculated excess of component.

Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

The building Jacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, closures, in-process materials, and drug products and to prevent contamination.