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# 7 Observations in Leiters Health FDA-483
- URL: https://www.fdaweb.com/7-observations-in-leiters-health-fda-483/
- Published: 2024-07-18T12:00:00.000Z
- Updated: 2026-09-14T14:35:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157385

FDA has released the form FDA-483 issued following a 3/20-4/5 inspection at Denver Solutions, an Englewood, CO, outsourcing facility doing business as Leiters Health. The seven inspection observations were:

- failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed;
- failure to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failure to fully follow the responsibilities and procedures applicable to the quality control unit;
- failure to follow the written stability testing program;
- failure to follow written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product;
- failure of the container of the outsourcing facility’s drug products to contain information required by the Federal Food, Drug, and Cosmetic Act (FFDCA); and
- failure of the labels of the outsourcing facility’s drug products to contain information required by the FFDCA.