Yichang Sanxia Pharmaceutical Co., Ltd. – FDA EIR, Sep 8, 2023

An FDA comprehensive surveillance inspection of Yichang Sanxia Pharmaceutical Co., Ltd., a foreign manufacturer of veterinary and human active pharmaceutical ingredients, was conducted from September 4-8, 2023. This announced inspection, part of the fiscal year 2023 surveillance plan, evaluated compliance with current Good Manufacturing Practices (cGMP) and international guidelines, specifically CP 7371.001, 73.56002F, and ICH Q7. The inspection covered the firm's quality, facilities and equipment, material, and packaging and labeling systems, with partial coverage of the laboratory system. Notably, no deficiencies were identified during this inspection, and consequently, no FDA Form 483 was issued. The inspection concluded with a "No Action Indicated" classification, meaning no regulatory action or follow-up is required by the FDA. The report also referenced a previous FDA inspection in July 2016, which had identified two observations: a lack of Quality Assurance assessment for product stability after changes in critical raw materials and inconsistent document practices. The current inspection confirmed that the company had successfully addressed and corrected these prior observations.