Guangzhou PharmaLab Co., Ltd. – FDA 483, Aug 30, 2023

Guangzhou PharmaLab Co., Ltd., a contract research organization in Guangzhou, China, received a Form 483 for significant deficiencies in data integrity and quality control. The inspection revealed a lack of appropriate controls over computerized systems, including selective data export and improper use of administrative accounts. Additionally, the quality unit failed to thoroughly investigate out-of-expectation results, did not follow established procedures for sample analysis, and lacked proper method transfer and communication processes with its contract laboratory.