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# QuVa Pharma Inspection Observations
- URL: https://www.fdaweb.com/quva-pharma-inspection-observations/
- Published: 2026-07-07T12:00:00.000Z
- Updated: 2026-09-14T13:42:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161416

FDA has released the form FDA-483 with three observations from a 4/20-5/04 inspection at the QuVa Pharma outsourcing facility in Sugar Land, TX. The specific inspection observations were:

- failure to establish and follow written procedures to prevent microbiological contamination of drug products purporting to be sterile;
- 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 the batch has already been distributed; and
- failure to maintain in a good state of repair buildings used in the manufacturing, processing, packing, and holding of a drug product.