Sunsho Pharmaceutical Co., Ltd. – FDA 483, Apr 17, 2025

During an FDA inspection conducted from April 14-17, 2025, at Sunsho Pharmaceutical Co., Ltd.'s dietary supplement manufacturing facility in Fuji-shi, Shizuoka, Japan, several significant deficiencies were observed. The inspection revealed that the company failed to establish crucial specifications for components, including identity, purity, strength, composition, and contamination limits for ingredients used in U.S.-bound dietary supplements. Furthermore, appropriate scientifically valid methods for testing these specifications were not consistently identified or used, with issues noted in identity testing procedures and a lack of standard reference materials. The inspection also highlighted the absence of comprehensive product specifications for finished dietary supplements destined for the U.S. market. Critical record-keeping deficiencies were identified in both batch production records (BPRs) and master manufacturing records (MMRs). BPRs lacked details such as equipment identity, cleaning dates, and in-process testing results, while MMRs were missing sampling procedures and written instructions for ingredient weighing. These observations indicate non-compliance with the regulatory framework governing Good Manufacturing Practices for dietary supplements. Sunsho Pharmaceutical Co., Ltd. is required to provide a robust response detailing corrective actions to address each of these findings.