# FDA WARNING_LETTER - Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. - March 22, 2024

Source: https://www.globalkeysolutions.net/records/warning_letter/tianjin-darentang-jingwanhong-pharmaceutical-co-ltd/371d4f60-a959-4d7b-9b6b-1f65f960c425

> FDA WARNING_LETTER for Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. on March 22, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.
- Inspection Date: 2024-03-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. following an inspection from March 18-22, 2024, which documented significant CGMP violations and inspection limitations/refusals.

The firm limited and refused the inspection by:
*   **Limiting Access to Records:** Providing unreasonably redacted manufacturing records (process validation reports, batch records, equipment qualification reports) and incomplete CAPA lists.
*   **Limiting Photography:** Prohibiting investigators from photographing dirty and disrepaired filling machines (ID-192, ID-197).
*   **Limiting Access to Areas:** Denying access to a manufacturing room where specific operations were performed.

These actions render the firm's drugs adulterated under section 501(j) of the FD&C Act.

Additional CGMP violations include:
1.  **Failure to Clean and Maintain Equipment (21 CFR 211.67(a)):** Investigators observed residues and disrepair on filling machines (ID-192, ID-197) despite being marked "clean." The firm's response regarding revised cleaning procedures and repairs was deemed inadequate, lacking a comprehensive CAPA plan for oversight and a retrospective assessment of cleaning effectiveness.
2.  **Failure to Establish Adequate Production and Process Controls (21 CFR 211.100(a)):** The

## Related Documents

- [483 - 2024-03-22](https://www.globalkeysolutions.net/records/483/tianjin-darentang-jingwanhong-pharmaceutical-co-ltd/7ee010d6-f98e-4201-8351-4cc71cae6bd1)

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.globalkeysolutions.net/companies/tianjin-darentang-jingwanhong-pharmaceutical-co-ltd/10618087-4dda-4a3c-b6b9-65fd81c65493

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c