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# STAQ Pharma Inspection FDA-483 Released
- URL: https://www.fdaweb.com/staq-pharma-inspection-fda-483-released/
- Published: 2020-11-04T12:00:00.000Z
- Updated: 2026-09-14T16:35:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148019

FDA has released the FDA-483 issued following an 8/25-9/3 inspection at STAQ Pharma, a Denver, CO, outsourcing facility. Specific inspection observations were: 

- failing to include the conclusions and follow-up in written records of investigations into unexplained discrepancies;
- failing to include adequate validation of the aseptic process in procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions; and
- labels on the facility’s drug products are deficient.