FDA 483 - Hisun Pharmaceutical (Nantong) Co., Ltd. - July 12, 2024

Hisun Pharmaceutical (Nantong) Co., Ltd., an API manufacturer in Nantong City, China, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for inadequate change control for new sampling devices, insufficient deviation investigations leading to repeat sampling errors, and poor equipment cleaning and maintenance practices. Additionally, the inspection revealed a lack of adequate written procedures for equipment cleaning and release.