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# Patheon Italia FDA-483 Out
- URL: https://www.fdaweb.com/patheon-italia-fda-483-out/
- Published: 2024-11-27T12:00:00.000Z
- Updated: 2026-09-14T14:48:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158271

FDA has released the form FDA-483 issued following a 5/18-5/26/2023 inspection at the Patheon Italia sterile drug manufacturing facility in Monza, Italy. The four inspection observations were:

- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failure to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use; and
- failure to store drug products under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.