US Specialty Formulations — FDA 483 Findings

Reserve samples from representative sample lots or batches of diug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.

Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile are not followed.

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 ah-eady distributed.

Laborato1y controls do not include dete1mination of confo1mance to appropriate written specifications for the acceptance ofeach lot within each shipment of components used in the manufacture, processing, packing, or holding ofdi11g products.

Testing and release ofm11g product for distribution do not include appropriate laborato1y dete1mination of satisfacto1y confo1mance to the final specifications and identity and strength of each active ingredient prior to release.

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

The quality control unit lacks the responsibility and authority to approve and reject all components, drng product containers, closures, in process materials, packaging material, labeling and drng products.