FDA 483 - Sunsho Pharmaceutical Co., Ltd. - April 17, 2025

During an inspection conducted from April 7 to April 17, 2025, the FDA identified significant quality system deficiencies at Sunsho Pharmaceutical Co., Ltd., a dietary supplement and acidified food manufacturer located in Fuji-shi, Shizuoka, Japan. The observations indicate a lack of adherence to manufacturing and quality control standards for products destined for the U.S. market.

Primary issues included a failure to establish complete specifications for identity, purity, strength, composition, and contamination limits for both raw materials and finished dietary supplements. The company also lacked scientifically valid methods for testing these specifications and could not demonstrate the use of standard reference materials for ingredient identity confirmation. Further deficiencies were noted in documentation, with Batch Production Records and Master Manufacturing Records found to be incomplete, missing details such as equipment identity, maintenance records, and real-time process documentation. The firm also failed to consistently follow its own Master Manufacturing Records and lacked adequate controls for packaging material reconciliation, including verifying the accuracy of electronic counting equipment. Sunsho Pharmaceutical Co., Ltd. must implement comprehensive corrective actions to address these findings and ensure full compliance with regulatory requirements for dietary supplement manufacturing.