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# ImprimisRx NJ FDA-483 Has 9 Observations
- URL: https://www.fdaweb.com/imprimisrx-nj-fda-483-has-9-observations/
- Published: 2022-11-09T12:00:00.000Z
- Updated: 2026-09-14T18:05:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153163

FDA has released the form FDA-483 with nine observations from a 7/11-8/5 inspection at ImprimisRx NJ, a Ledgewood, NJ, producer of sterile and non-sterile drug products. The inspection observations were:

- the ISO 5 classified aseptic processing areas had visibly dirty equipment or surface;
- personnel did not disinfect and change gloves frequently enough to prevent contamination;
- materials or supplies were not disinfected before entering the aseptic processing area;
- the use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic processing area was inadequate;
- the facility design allowed the influx of poor quality air into a higher classified area;
- the segregated production areas surrounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without adequate and frequent cleaning;
- non-microbial contamination was observed in the production area;
- the firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess; and
- ISO classified areas were not certified under dynamic conditions.