FDA 483 - ideal specialty apothecary, inc. - November 18, 2021

Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy in Union, New Jersey, was cited for significant deficiencies in aseptic processing and environmental control during an FDA inspection. Observations included inadequate certification of ISO-5 areas, insufficient media fill simulations, poor environmental segregation, and widespread non-microbial and microbial contamination. The firm also compounded drugs during adjacent construction without proper contamination controls, indicating a high severity of issues impacting product sterility and quality.