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# 7 Observations on ProRx FDA-483
- URL: https://www.fdaweb.com/7-observations-on-prorx-fda-483/
- Published: 2025-12-16T12:00:00.000Z
- Updated: 2026-09-14T15:29:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160397

FDA has released the form FDA-483 issued following a 9/9-9/19 inspection at the ProRx outsourcing facility in Exton, PA. 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 already been distributed;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failure to establish and follow written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- 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;
- the quality control unit lacks the responsibility to approve and reject all procedures or specifications affecting drug product quality;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce sterile conditions; and
- failure of the labels of the outsourcing facility’s drug products to include information required by the Federal Food, Drug, and Cosmetic Act.