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# FDA Publishes Qualgen ’483
- URL: https://www.fdaweb.com/fda-publishes-qualgen-483/
- Published: 2017-06-01T12:00:00.000Z
- Updated: 2026-09-14T22:26:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138833

FDA has published the [FDA-483](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm560347.pdf?ref=fdaweb.com) issued following a 4/17-5/10 agency inspection at Qualgen, Edmond, OK, an outsourcing facility. The five inspection observations were: 

- failing 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 already distributed;
- failing to have procedures designed to prevent microbiological contamination of drug products purporting to be sterile include validation of the sterilization process;
- deficiency in separate or defined areas and control systems necessary to prevent contamination or mix-ups;
- failing to establish and follow written procedures that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each branch; and
- failing to test through appropriate laboratory testing each batch of drug product required to be free of objectionable microorganisms.