FDA 483 - Minsheng Group Shaoxing Pharmaceutical Co., Ltd. - November 15, 2024

Minsheng Group Shaoxing Pharmaceuticals Co. Ltd. in Shaoxing, P.R. China, received a Form 483 with seven observations related to significant deficiencies in their quality control and manufacturing processes for Active Pharmaceutical Ingredients (APIs). Key issues include inadequate stability testing, improper handling of out-of-specification results, insufficient quality unit oversight, and failures in equipment cleaning and personnel training. These observations indicate a systemic lack of adherence to cGMP principles, posing a risk to product quality and patient safety.