FDA WARNING_LETTER - Yangzhou Yulou Paper Products Co., Ltd. - September 09, 2025

Yangzhou Yulou Paper Products Co., Ltd., located at No. 888 Jinbao West Road, Baoying County, Yangzhou, Jiangsu, China, received an FDA Warning Letter dated September 9, 2025, following an inspection and review of records. The inspection, conducted under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, as outlined in Title 21 Code of Federal Regulations, parts 210 and 211.

Key violations include the failure to establish and follow procedures to prevent microbiological contamination of sterile drug products, inadequate identity testing of drug components, lack of a stability testing program, absence of process validation, and insufficient quality control procedures. Specifically, the firm did not demonstrate that their products, labeled as sterile, were manufactured using validated aseptic processes, nor did they conduct necessary sterility testing. Additionally, the firm did not perform identity testing on incoming components, nor did they have stability data to support product shelf life.

The FDA requires Yangzhou Yulou Paper Products Co., Ltd. to address these deficiencies by providing evidence of corrective actions, including the establishment of validated procedures for sterility assurance, component testing, stability studies, process validation, and the implementation of a robust quality control unit. The firm must ensure compliance with CGMP regulations to continue manufacturing OTC drug products for the U.S. market.