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# QuVa Pharma FDA-483 Released
- URL: https://www.fdaweb.com/quva-pharma-fda-483-released/
- Published: 2018-05-02T12:00:00.000Z
- Updated: 2026-09-15T00:02:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141347

FDA has released the FDA-483 with four observations issued following a 4/16-4/20 inspection at QuVa Pharma, a Temple, TX, drug outsourcing facility. Specific inspection observations were: 

- the quality control unit lacks authority to fully investigate errors that have occurred;
- written records of investigations of a drug complaint do not include investigation findings;
- 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; and
- separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.