# Chengdu Shengnuo Biopharm Co Ltd – FDA 483, Aug 27, 2026

Source: https://www.keypedia.com/records/483/chengdu-shengnuo-biopharm-co-ltd/a7cd067e-1b0c-424b-a2e8-a52a3c2ec61d

> FDA 483 for Chengdu Shengnuo Biopharm Co Ltd on August 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chengdu Shengnuo Biopharm Co Ltd
- Inspection Date: 2026-08-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Chengdu Shengduo Biopharm Co., Ltd., an API manufacturer in Dayi Country, China, was cited for numerous significant Good Manufacturing Practice (GMP) violations during an FDA inspection. These issues include inadequate test method validation, insufficient process validation, poor facility and equipment cleanliness, critical equipment maintenance failures, and a systemic breakdown in quality unit oversight and investigations. The findings indicate a severe lack of control over manufacturing processes, potentially compromising the quality, safety, and purity of their APIs.

## Related Documents

- [483 - 2023-09-08](https://www.keypedia.com/records/483/chengdu-shengnuo-biopharm-co-ltd/3a5fc8ce-c04d-40a6-8c94-70d6a944c6dc) — date: September 8, 2023

## Related Officers

- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)
- [Investigator](https://www.keypedia.com/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)
- [Crystal Monroy](https://www.keypedia.com/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)
- [Yoonhee Kim](https://www.keypedia.com/people/yoonhee-kim/4caba86b-1126-40d9-a90d-c9975413c66b)

Company: https://www.keypedia.com/companies/chengdu-shengnuo-biopharm-co-ltd/7e22dc83-be1b-41e1-af8c-856dd7a35375

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8