FDA 483 - Nanjing Cuccess Pharmaceutical Co., Ltd. - March 21, 2025

Nanjing Cuccess Pharmaceutical Co., Ltd., located in Nanjing, China, underwent an FDA inspection from March 17 to March 21, 2025. The inspection identified significant deficiencies in the facility’s adherence to drug manufacturing standards. Primary violations centered on equipment maintenance, sanitation, and laboratory oversight. Specifically, investigators found visible residues and soiling in shared-use equipment, such as hoses and formulation vessels used for both hazardous and commercial drugs. Current cleaning procedures were insufficient to reach critical components like seals and gaskets, creating a high risk of cross-contamination. Additionally, the firm failed to properly qualify its stability chambers. Requalification processes used scientifically unjustified methods, such as adding non-stability materials to simulate full loads, and sensors were poorly positioned to monitor environmental conditions accurately. Finally, the laboratory failed to follow its stability testing program, releasing and distributing drug products without the required accelerated stability data to support their assigned shelf life. While these observations are not a final determination of non-compliance, the company is expected to respond to the FDA with a comprehensive corrective action plan. This response must detail how the firm will improve sanitation protocols, validate equipment performance, and ensure that all laboratory testing aligns with regulatory requirements for product safety and quality.