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# 7 Observations on U.S. Specialty FDA-483
- URL: https://www.fdaweb.com/7-observations-on-u-s-specialty-fda-483/
- Published: 2024-11-13T12:00:00.000Z
- Updated: 2026-09-14T14:46:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158177

FDA has released the form FDA-483 that was issued following a 6/17-7/2 inspection at the U.S. Specialty Formulations outsourcing facility in Allentown, PA. The seven inspection observations were:

- the quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, in-process materials, packaging material, labeling, and drug products;
- laboratory controls do not include the determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of components used in the manufacture, processing, packing, or labeling of drug products;
- failure of the written stability program for drug products to include reliable, meaningful, and specific test methods;
- failure of testing and release of drug product for distribution to include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient before release;
- failure to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failure to examine visually reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures at least once a year for evidence of deterioration; and
- 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 already been distributed.