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# Hikma Injectables Hit With 3-item FDA-483
- URL: https://www.fdaweb.com/hikma-injectables-hit-with-3-item-fda-483/
- Published: 2022-10-20T12:00:00.000Z
- Updated: 2026-09-14T18:03:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153018

A recent inspection at Hikma Injectables USA (Dayton, OH) has led to a three-item [Form FDA-483](https://www.fda.gov/media/162407/download?ref=fdaweb.com). For example, agency investigators cited the firm’s aseptic processing areas because they did not have adequate monitoring of environmental conditions. The agency also said Hikma’s aseptic processing areas were “deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.” Additionally, the inspection found that the number of batches placed on stability testing were not adequate to determine an appropriate expiration date.