FDA 483 - Jiangsu Tohope Pharmaceutical Co., Ltd. - August 31, 2018

This summary outlines the findings from an FDA inspection of Jiangsu Tohope Pharmaceutical Co., Ltd., located in Jiangsu, China. The inspection took place between August 29 and August 31, 2018, focusing on the company"s dietary supplement manufacturing operations. During this period, investigators identified a significant lapse in quality control procedures involving the maintenance of laboratory equipment. Specifically, the inspection revealed that quality control personnel failed to document the calibration of a pH meter. The device"s logbook lacked any calibration entries from July 5, 2018, through August 30, 2018. This particular instrument was used to adjust the pH buffer solutions required for testing finished products, specifically Alpha Lipoic Acid. The inspection was conducted under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which aims to ensure that products are not prepared or held under conditions that could compromise their safety or quality. While this Form 483 represents preliminary observations and not a final determination of compliance, the company is expected to take corrective action. Jiangsu Tohope Pharmaceutical is encouraged to submit a formal response to the FDA detailing their plan to address these documentation gaps and ensure that all testing equipment is regularly calibrated and recorded to maintain product integrity.