# FDA 483 - Huangshi Hygienic Material Medicine Co., Ltd. - August 30, 2024

Source: https://www.keypedia.com/records/483/huangshi-hygienic-material-medicine-co-ltd/04cda052-522d-47fb-94b6-d9c82e2c260d

> FDA 483 for Huangshi Hygienic Material Medicine Co., Ltd. on August 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huangshi Hygienic Material Medicine Co., Ltd.
- Inspection Date: 2024-08-30
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: Huangshi Hygienic Material Medicine Co., Ltd. in Huangshi, China, was inspected and cited for significant deficiencies across multiple areas of its drug manufacturing operations. Key issues include inadequate stability and microbial testing, poor equipment cleaning and maintenance, lack of data integrity review, and facility disrepair. These observations indicate a systemic failure to adhere to good manufacturing practices for drug products intended for the US market.

## Related Documents

- [WARNING_LETTER - 2024-08-30](https://www.keypedia.com/records/warning_letter/huangshi-hygienic-material-medicine-co-ltd/41195760-1a06-4893-9965-508f30ff2610)

## Related Officers

- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

Company: https://www.keypedia.com/companies/huangshi-hygienic-material-medicine-co-ltd/a58f7a79-14fb-4e0c-b1d6-b05bbbc6183f

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917