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

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.

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

Written production and process control procedures are not followed in the execution of production and process control functions.

The master production and control records are deficient in that they do not include complete manufacturing, control, and instructions.

Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.

Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing of the drug product.

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

Each batch of drug product required to be tree of objectionable microorganisms is not tested through appropriate laboratory testing.

Reserve samples for drug products are not retained for one year after the expiration date of the drug product.