FDA 483 - Jilin Shulan Synthetic Pharmaceutical Co. Ltd. - November 07, 2026

Jilin Shulan Synthetic Pharmaceutical, Co., Ltd. in Shulan City, China, was cited for severe data integrity and quality control failures during an FDA inspection. Observations included widespread manipulation of batch records, lack of quality oversight, inadequate computer system controls, and failure to investigate deviations. These issues indicate a systemic breakdown in ensuring product quality and regulatory compliance.