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# 15 Observations in Advanced Nutriceuticals FDA-483
- URL: https://www.fdaweb.com/15-observations-in-advanced-nutriceuticals-fda-483/
- Published: 2020-12-16T12:00:00.000Z
- Updated: 2026-09-14T16:40:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148320

FDA has released the FDA-483 containing 15 observations issued following a 10/13-10/29 inspection at Advanced Nutriceuticals, an Indianapolis, IN, producer of sterile drug products. The inspection observations were: 

- performing aseptic processing outside of a certified ISO 5 area;
- the ISO classified aseptic processing area was located within a non-classified room;
- employees touched equipment and other surface areas outside the ISO 5 area with gloved hands and proceeded to aseptically process drug product without changing or sanitizing gloves;
- a sterile technician moved rapidly in the vicinity of open sterile units or instruments;
- a sterile technician conducted aseptic manipulation and placed equipment/supplies in an area that blocks the movement of first-pass air around an open unit;
- a sterile technican stoppered sterile drug vials;
- supplies outside of the ISO 5 cleanroom hood were not disinfected before entering the aseptic processing area;
- systems for monitoring processing and environmental conditions in aseptic processing areas were deficient;
- the firm exposed stock solutions used in the production of drug products intended to be sterile to worse-than-ISO 5-quality air;
- inadequate use of sporicidal agents in the aseptic processing area;
- failing to sterilize the final containers/closures used for drug products intended to be sterile;
- an employee produced a sterile drug product using expired material;
- the ISO-classified aseptic processing areas and surrounding areas had difficult-to-clean and visibly dirty equipment or surfaces;
- facility design allowed the influx of poor-quality air into a higher classified area; and
- beta-lactam and hazardous drugs were produced without providing adequate containment, segregation, and cleaning of work surfaces, utensils, and personnel to prevent cross-contamination.