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# 3 Observations in STAQ Pharma Inspection
- URL: https://www.fdaweb.com/3-observations-in-staq-pharma-inspection-d5161830/
- Published: 2026-09-23T16:00:00.000Z
- Updated: 2026-09-23T16:00:00.000Z
- Author: David McFarland
- Tags: Drugs, Legacy-ID-D5161830, #Import 2026-09-24 19:50

FDA has released the[ Form FDA-483](https://www.fda.gov/media/194821/download?ref=fdaweb.com) with three observations from its 8/10-8/19 inspection at the STAQ Pharma Ohio outsourcing facility in Columbus, OH. The inspection observations were:

- failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
- failure of batch production and control records to include in-process results for each batch of drug product produced; and
- failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the aseptic and sterilization process.