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# 6 Observations in Fagron Outsourcing Inspection
- URL: https://www.fdaweb.com/6-observations-in-fagron-outsourcing-inspection/
- Published: 2025-09-18T12:00:00.000Z
- Updated: 2026-09-14T15:22:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159892

FDA has released the form FDA-483 issued following a 7/29-8/8 inspection at Fagron Compounding Services, a Wichita, KS, outsourcing facility. The six inspection [observations](https://www.fda.gov/media/188683/download?ref=fdaweb.com) were:

- failure to establish and follow written procedures to prevent microbiological contamination of drug products purporting to be sterile;
- 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 already been distributed;
- failure to maintain in a good state of repair buildings used in the manufacturing, processing, packing, and holding of a drug product;
- the number of qualified personnel is inadequate to perform the manufacture of each drug product;
- buildings used in the manufacture, processing, packing, or holding of a drug product do not have a suitable size to facilitate cleaning, maintenance, and proper operations; and
- failure to establish and follow written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, and holding of a drug product.