FDA 483 - Qingdao BAHEAL Pharmaceutical Co.,Ltd. - December 06, 2019

Qingdao BAHEAL Pharmaceutical Co., Ltd., a drug manufacturer in Jimo, China, was cited for significant deficiencies during an FDA inspection from December 2-6, 2019. Observations included inadequate equipment cleaning and maintenance, insufficient written procedures for cleaning, incomplete batch production records, and critical failures in computer system controls leading to data integrity concerns. These issues indicate a lack of control over manufacturing processes and data, potentially impacting drug product quality and safety.