FDA 483 - ideal specialty apothecary, inc. - November 18, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · a6188d77-0af0-42ab-9b19-44998da28566