# FDA 483 - Wuhu Nuowei Chemistry Co., Ltd - September 06, 2024

Source: https://www.keypedia.com/records/483/wuhu-nuowei-chemistry-co-ltd/05b68bd8-d216-47cf-82ad-690777a79450

> FDA 483 for Wuhu Nuowei Chemistry Co., Ltd on September 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuhu Nuowei Chemistry Co., Ltd
- Inspection Date: 2024-09-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Wuhu Nuowei Chemistry Co., Ltd, a pharmaceutical manufacturer in Wuhu, Anhui, China, was inspected by the FDA and found to have significant deficiencies. The inspection revealed an inadequate quality control unit, failures in establishing and validating cleaning protocols for production equipment, and a lack of validation and verification for test methods used in manufacturing. These issues indicate a lack of adequate controls to ensure product quality and prevent contamination for products released to the USA market.

## Related Documents

- [WARNING_LETTER - 2024-09-06](https://www.keypedia.com/records/warning_letter/wuhu-nuowei-chemistry-co-ltd/77fa83b5-ed71-4e9b-adc1-dbbae59044fa)

## Related Officers

- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)
- [Carolina D. Vasquez](https://www.keypedia.com/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)

Company: https://www.keypedia.com/companies/wuhu-nuowei-chemistry-co-ltd/1630632a-a572-456a-a568-71381b1b57d2

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