US Specialty Formulations LLC — 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.

Drug products failing to meet established specifications are not rejected.

Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written.

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

Results of stability testing are not used in determining expiration dates.

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

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

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.

The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.

Written procedures for sampling and testing plans are not followed for each drug product.

The labels of your outsourcing facility's drug products are deficient.