FDA 483 - Changzhou Sunlight Pharmaceutical Co., Ltd. - May 31, 2024

Changzhou Sunlight Pharmaceutical Co., Ltd., an API manufacturer, was inspected by the FDA. The inspection revealed a significant issue where equipment used in the manufacturing of API intermediates was not operating within its appropriate range. This included discrepancies between set and actual parameters and the use of recording instruments with incorrect ranges, indicating potential quality control failures.