Bentley Laboratories LLC — FDA 483 Findings

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

There is a failure to thoroughly review any unexplained discrepancy, 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.

Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

The written stability program for drug products does not include reliable, meaningful, and specific test methods.

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications, identity and strength of each active ingredient prior to release.

The suitability of all testing methods is not verified under actual conditions of use.

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.