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# 3 Observations on Hikma FDA-483
- URL: https://www.fdaweb.com/3-observations-on-hikma-fda-483/
- Published: 2024-07-11T12:00:00.000Z
- Updated: 2026-09-14T14:35:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157332

FDA has released the form FDA-483 issued following a 5/29-6/12 inspection at the Hikma Pharmaceuticals USA outsourcing facility in Cherry Hill, NJ. The three inspection observations were:

- failure to establish and follow procedures designed to prevent objectionable microorganisms in drug products not required to be sterile;
- failure to have laboratory controls include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength quality, and purity; and
- failure to fully follow the responsibilities and procedures applicable to the quality control unit.