# FDA 483 - Sichuan Huiyu Pharmaceutical Co., Ltd. - November 06, 2025

Source: https://www.keypedia.com/records/483/sichuan-huiyu-pharmaceutical-co-ltd/3810b919-5a63-46e1-bf2c-41c79bf175d7

> FDA 483 for Sichuan Huiyu Pharmaceutical Co., Ltd. on November 06, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sichuan Huiyu Pharmaceutical Co., Ltd.
- Inspection Date: 2025-11-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Sichuan Huiyu Pharmaceutical Co., Ltd. revealed significant deficiencies across its quality control, laboratory, and production systems. The firm failed to adequately investigate and reject potentially contaminated batches, maintain proper environmental monitoring, and ensure equipment sanitation. Additionally, there were systemic issues with complaint handling, OOS investigations, and the completeness of batch production records, indicating a broad lack of adherence to cGMP regulations.

## Related Documents

- [483 - 2022-07-18](https://www.keypedia.com/records/483/sichuan-huiyu-pharmaceutical-co-ltd/a3bbe703-9950-4b1a-b424-24864e6a9626)
- [483 - Unknown Date](https://www.keypedia.com/records/483/sichuan-huiyu-pharmaceutical-co-ltd/11158f41-55b1-4138-80a3-91a1b64884eb)

## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)
- [Tonia F. Bernard](https://www.keypedia.com/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.keypedia.com/companies/sichuan-huiyu-pharmaceutical-co-ltd/7be6f8c0-7ce4-4fee-9ee6-661656f79582

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