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

An FDA Form 483 was issued to Changzhou Sunlight Pharmaceutical Co., Ltd. following an inspection conducted from May 27 to May 31, 2024. The inspection of this active pharmaceutical ingredient (API) manufacturer revealed significant observations concerning its production processes. The primary concern highlighted was that equipment vital for manufacturing intermediate components of APIs was not operating within its appropriate and intended range. Specifically, the FDA investigators observed discrepancies in process control. In one instance, the set temperature for manufacturing an intermediate differed from the actual recorded temperature, indicating a failure to maintain specified process parameters. Furthermore, pressure readings for another manufacturing step were being taken using a manometer with a range unsuitable for the required in-process specifications. This suggests inadequate equipment selection or calibration for critical process monitoring. These observations point to potential deficiencies in the company's quality control and adherence to current Good Manufacturing Practices, which mandate precise control and monitoring of manufacturing environments and processes to ensure product quality and consistency. While the FDA 483 document itself is not a final determination of non-compliance, it requires the company to address these issues and propose comprehensive corrective and preventive actions to ensure all equipment operates as intended and critical process parameters are accurately maintained and monitored.