MasterPharm FDA-483 Released

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 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.