FDA 483 - Nanhai Beisha Pharmaceutical Co., Ltd. - September 19, 2025

An FDA inspection of Nanhai Beisha Pharmaceutical Co., Ltd. in Nanhai, China, revealed four significant observations concerning its API manufacturing operations. The firm failed to maintain accurate and contemporaneous documentation, control written records, and establish adequate cleaning procedures for equipment. Additionally, raw materials were not stored under appropriate temperature conditions, indicating a lack of adherence to GMP requirements.