# FDA 483 - Anhui Hanbon Daily Chemical Co., Ltd. - February 28, 2025

Source: https://www.globalkeysolutions.net/records/483/anhui-hanbon-daily-chemical-co-ltd/563c7b1b-18c9-4420-85ea-342a1a0cc4f8

> FDA 483 for Anhui Hanbon Daily Chemical Co., Ltd. on February 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anhui Hanbon Daily Chemical Co., Ltd.
- Inspection Date: 2025-02-28
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Anhui Hanbon Daily Chemical Co., Ltd., an OTC manufacturer in Huainan, China, revealed significant deficiencies across its quality system, production, and laboratory controls. The firm failed to establish and follow adequate procedures for annual product reviews, process controls, test method validation, raw material identity testing, and stability studies. Additionally, laboratory equipment was not properly qualified or calibrated, indicating a severe lack of control over drug product quality.

## Related Officers

- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)

Company: https://www.globalkeysolutions.net/companies/anhui-hanbon-daily-chemical-co-ltd/8010553b-8f36-4b90-8247-25ea0a7019e9

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