FDA 483 - Hunan Norchem Pharmaceutical Co. Ltd. - July 28, 2017

Hunan Norchem Pharmaceutical Co., Ltd. in Jinshi, China, received a Form 483 with nine observations following an inspection from July 24-28, 2017. The inspection revealed significant deficiencies in the firm's quality unit, including failures in process and cleaning validation, record retention, raw material control, and quality control testing for their (b)(4) Base API. These issues indicate a systemic lack of adherence to GMP requirements, posing a risk to product quality and patient safety.