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# 4 Observations in AnazaoHealth Inspection
- URL: https://www.fdaweb.com/4-observations-in-anazaohealth-inspection/
- Published: 2025-09-02T12:00:00.000Z
- Updated: 2026-09-14T15:20:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159793

FDA has released the form FDA-483 with four observations from a 7/29-8/8 inspection at AnazaoHealth, a Las Vegas, NV, outsourcing facility. The four inspection [observations](https://www.fda.gov/media/188525/download?ref=fdaweb.com) were:

- failure to establish adequate written procedures for production and process controls designed to assure that drug products have the identity, strength, purity, and quality that they are purported or represented to possess;
- failure to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- complaint records are deficient in that they do not include the findings of the investigation and follow-up; and
- failure of laboratory records to include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards.