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# 6 Observations in Sharp Drug FDA-483
- URL: https://www.fdaweb.com/6-observations-in-sharp-drug-fda-483/
- Published: 2018-08-01T12:00:00.000Z
- Updated: 2026-09-15T00:23:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142023

FDA has released the FDA-483 issued following a 7/10-7/13 inspection at Sharp Drugs, a West Hampton Beach, NY, producer of sterile and non-sterile drugs. The inspection observations were: 

- ISO 5 classified aseptic processing area located within a non-classified room (segregated production area);
- disinfecting agents, cleaning pads, and cleaning wipes used in the ISO 5 classified area were not sterile;
- personnel engaged in aseptic processing wear non-sterile gloves;
- media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations;
- materials or supplies were not disinfected prior to entering the aseptic processing area; and
- environmental monitoring was not performed in aseptic processing areas.