483
Jilin Shulan Synthetic Pharmaceutical Co. Ltd.FDA 483 - Jilin Shulan Synthetic Pharmaceutical Co. Ltd. - November 07, 2026
Record Details
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.
- Inspection Date
- November 7, 2026
- Product Type
- Drugs
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ID · 61b255fc-1046-4e28-8fa5-0592cb64616c