Nitto Denko Avecia Inc. – FDA 483, Feb 8, 2023

An FDA inspection of Nitto Denko Avecia Inc., an API manufacturer in Milford, MA, revealed significant deficiencies across its quality systems. Observations included inadequate deviation investigations, poor retention and security of batch records, failure to adhere to stability testing procedures, and untimely review of quality reports. Additionally, the facility exhibited inadequate cleaning of manufacturing areas and equipment, indicating a broad lack of GMP compliance.