FDA 483 - Nanchang Anobri Pharmaceutical CO., LTD - November 13, 2023

Nanchang Anobri Pharmaceutical CO., LTD, a drug product manufacturer in Nanchang City, Jiangxu, was cited for significant deficiencies across its quality, laboratory, material, production, facilities, equipment, design, audit, process validation, document, and personnel systems. Key issues include inadequate quality unit review, deficient HPLC peak integration, incomplete batch records, and insufficient validation and control procedures for both drug products and drug-device combination products. These findings indicate a broad lack of adherence to established procedures and regulatory requirements, potentially impacting product quality and data integrity.