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# Hikma Injectables FDA-483 Out
- URL: https://www.fdaweb.com/hikma-injectables-fda-483-out/
- Published: 2025-08-27T12:00:00.000Z
- Updated: 2026-09-14T15:20:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159767

FDA has released the form FDA-483 issued following a 7/28-8/9 inspection at Hikma Injectables USA, Inc., a Dayton, NJ, outsourcing facility. The four inspection observations were:

- failure to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess;
- failure to clean, maintain, and sanitize equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions; and
- failure to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile.