Main Street Family Pharmacy — FDA 483 Findings

Specifically, your firm does not have written and approved procedures for the processing/packaging/storage of injectable drug products.

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

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

There is a failure to thoroughly review 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 was a failure to handle and store drug product containers at all times in a manner to prevent contamination.

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

Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.

Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

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

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

There is no quality control unit.

Distribution records do not contain the lot or control number of drug product.

There is a lack of written procedures assigning responsibility, providing cleaning schedules, and describing in sufficient detail the methods, equipment and materials to be used for sanitation.

Batch production and control records do not include complete information relating to the production and control of each batch.

GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

Written records of major equipment cleaning, maintenance, and use are not included in individual equipment logs.

Procedures describing the handling of all written and oral complaints regarding a drug product are not established and written.

A sample which is representative of each lot in each shipment of each active ingredient is not retained.

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

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

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.

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

Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations.

Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product Specifically, a) your finn docs not use any type of sporicidal cleaning agent, inside or outside of the ISO 6 cleanroom, which contains three ISO 5 hoods used In the processing of injectable drug products.

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.