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# 3 Observations in Atlas Pharmaceuticals FDA-483
- URL: https://www.fdaweb.com/3-observations-in-atlas-pharmaceuticals-fda-483/
- Published: 2021-11-04T12:00:00.000Z
- Updated: 2026-09-14T17:21:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150519

FDA has released the FDA-483 issued following a 5/3-5/21 inspection at Atlas Pharmaceuticals, a Phoenix, AZ, outsourcing facility. The three inspection [observations](https://www.fda.gov/media/153337/download?ref=fdaweb.com) were: 

- failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- determinations of conformance to appropriate written specifications for acceptance are deficient for drug products; and
- failing of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the aseptic and sterilization process.