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# 6 Observations in QuVa Pharma Inspection
- URL: https://www.fdaweb.com/6-observations-in-quva-pharma-inspection/
- Published: 2019-07-25T12:00:00.000Z
- Updated: 2026-09-15T01:40:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144616

FDA has released the FDA-483 issued following a 5/7-5/31 inspection at QuVa Pharma, a Bloomsbury, NJ, outsourcing facility. The six inspections observations were: 

- the quality control unit lacks responsibility to approve and reject all procedures or specifications affecting the identity, strength, quality, and purity of drug products;
- written records of investigation of a drug complaint do not include findings of the investigation and the follow-up;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the aseptic process;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- laboratory controls do not include establishment of scientifically sound and appropriate test procedures designed to assure that they conform to appropriate standards of identity, strength, quality, and purity; and
- establishment of the reliability of the component supplier’s report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.