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# Innoveix FDA-483 Released
- URL: https://www.fdaweb.com/innoveix-fda-483-released/
- Published: 2019-11-06T12:00:00.000Z
- Updated: 2026-09-14T15:52:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145435

FDA has released the FDA-483 with seven observations issued following an 8/27-9/11 inspection at Innoveix Pharmaceuticals, an Addison, TX, producer of sterile and non-sterile drug products. The inspection observations were: 

- unprotected product intended to be sterile was exposed to lower than ISO 5 classified aseptic processing area quality air;
- facility design allowed the influx of poor quality air into a higher classified area;
- personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves;
- disinfectant contact time and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection;
- equipment was not disinfected prior to entering the aseptic processing areas;
- personnel donned gowning apparel improperly in a way that may have caused the gowning apparel to become contaminated; and
- the ISO 5 classified aseptic processing areas had particle-generating and visibly dirty equipment or surface.