# FDA WARNING_LETTER - Jilin Shulan Synthetic Pharmaceutical Co. Ltd. - August 28, 2009

Source: https://www.globalkeysolutions.net/records/warning_letter/jilin-shulan-synthetic-pharmaceutical-co-ltd/9ee1f554-90bc-4e45-85c3-2fc1014cd74c

> FDA WARNING_LETTER for Jilin Shulan Synthetic Pharmaceutical Co. Ltd. on August 28, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Jilin Shulan Synthetic Pharmaceutical Co. Ltd.
- Inspection Date: 2009-08-28
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. on May 13, 2010, following an August 24-28, 2009 inspection of their API manufacturing facility in China. The inspection revealed significant Current Good Manufacturing Practice (CGMP) deviations, rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's October 12, 2009, response was deemed insufficient.

Key violations included:
1.  **Production Deviations:** Failure to report, evaluate, and investigate critical production deviations, such as out-of-range equipment parameters and inadequate shift changeovers.
2.  **Master Production Records:** Incomplete master production records lacking critical manufacturing steps (e.g., (b)(4) stage) and inaccurate batch production records. Concerns were raised about the quality of recovered (b)(4).
3.  **Facility Design and Maintenance:** Buildings and facilities were not designed to facilitate cleaning and minimize contamination, with issues like peeling tape, accumulated debris, rusty equipment, and improper cleaning procedures. Uncovered in-process materials and improperly closing doors were also observed.
4.  **Quality Unit Failures:** Failure to reject APIs contaminated with foreign material (e.g., glass from a broken light, "black spots"), and performing maintenance during production.
5.

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/richard-l-friedman/2827edf4-7dbd-4430-96b2-87853c27e113)

Company: https://www.globalkeysolutions.net/companies/jilin-shulan-synthetic-pharmaceutical-co-ltd/50259969-13e0-4a14-ba2e-f8a4e8800f20

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