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# 10-item FDA-483 to Innoveix Pharmaceuticals
- URL: https://www.fdaweb.com/10-item-fda-483-to-innoveix-pharmaceuticals/
- Published: 2021-11-03T12:00:00.000Z
- Updated: 2026-09-14T17:21:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150513

An FDA inspection in May led to a 10-item [Form FDA-483](https://www.fda.gov/media/152617/download?ref=fdaweb.com) issued to Innoveix Pharmaceuticals (Addison, TX) that took issue with the firm’s GMPs for sterile drug products. For example, the agency said the firm failed to conduct media fills that closely simulate aseptic production operations under the worst case, most challenging and stressful conditions. The inspection also cited Innoveix over its method suitability, which had not been conducted for drug products that are sent for sterility testing. And, the firm was cited for using a non-pharmaceutical grade detergent to clean and sanitize glassware used in the production of injectable drug products.