# Nanjing Chengong Pharmaceutical Co., Ltd. – FDA 483, Sep 11, 2026

Source: https://www.keypedia.com/records/483/nanjing-chengong-pharmaceutical-co-ltd/7057b154-6f24-4b37-9ad5-0107dd39a6ae

> FDA 483 for Nanjing Chengong Pharmaceutical Co., Ltd. on September 11, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nanjing Chengong Pharmaceutical Co., Ltd.
- Inspection Date: 2026-09-11
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Nanjing Chengong Pharmaceutical Co. Ltd., an API manufacturer in Nanjing, China, was cited for significant deficiencies related to the accuracy and traceability of Certificates of Analysis (CoAs) for distributed Active Pharmaceutical Ingredients. The firm failed to adequately test, review, and approve CoAs for third-party manufactured APIs, and lacked an effective quality management system to ensure the authenticity and traceability of these products. Furthermore, the company did not maintain transparency regarding the original manufacturers of APIs distributed to the United States market.

## Related Documents

- [483 - 2025-03-21](https://www.keypedia.com/records/483/nanjing-chengong-pharmaceutical-co-ltd/adb707b7-02bb-489e-b3a0-219958fbeba0) — date: March 21, 2025

## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)
- [Pearl C. Ozuruigbo](https://www.keypedia.com/people/pearl-c-ozuruigbo/28ec383e-a602-4764-8d14-20b1049f93d7)

Company: https://www.keypedia.com/companies/nanjing-chengong-pharmaceutical-co-ltd/34bd5da4-2efe-4abc-9322-6847e76f7dda

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3