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

Source: https://www.globalkeysolutions.net/records/483/jilin-shulan-synthetic-pharmaceutical-co-ltd/61b255fc-1046-4e28-8fa5-0592cb64616c

> FDA 483 for Jilin Shulan Synthetic Pharmaceutical Co. Ltd. on November 07, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jilin Shulan Synthetic Pharmaceutical Co. Ltd.
- Inspection Date: 2026-11-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2017-11-10](https://www.globalkeysolutions.net/records/warning_letter/jilin-shulan-synthetic-pharmaceutical-co-ltd/065f5375-0619-4435-b40e-1b83311b9692)

## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.globalkeysolutions.net/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)

Company: https://www.globalkeysolutions.net/companies/jilin-shulan-synthetic-pharmaceutical-co-ltd/c7182328-88a3-48b2-8be3-1660603b27b3

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd