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# MasterPharm FDA-483 Released
- URL: https://www.fdaweb.com/masterpharm-fda-483-released/
- Published: 2020-08-05T12:00:00.000Z
- Updated: 2026-09-14T16:23:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147366

FDA has released the FDA-483 issued following a 5/28-29 and 6/1-6/15 inspection at MasterPharm, a South Richmond Hill, NY, producer of sterile and non-sterile drug products. The [report’s](https://www.fda.gov/media/140568/download?ref=fdaweb.com) inspection observations were: 

- releasing drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess;
- the ISO classified aseptic processing areas have difficult to clean, particle-generating, and visibly dirty equipment and surfaces;
- non-microbial contamination observed in the production area;
- hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination;
- ISO classified areas were not certified under dynamic conditions;
- there is a lack of adequate personnel sampling; and
- the facility design allows the influx of poor quality air into a higher classified area.