# FDA 483 - Bright Future Pharmaceutical (Hainan) Co., Ltd. - July 11, 2022

Source: https://www.keypedia.com/records/483/bright-future-pharmaceutical-hainan-co-ltd/1613cab7-e227-4805-ba75-415bfcb2aac2

> FDA 483 for Bright Future Pharmaceutical (Hainan) Co., Ltd. on July 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bright Future Pharmaceutical (Hainan) Co., Ltd.
- Inspection Date: 2022-07-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Bright Future Pharmaceutical (Hainan) Co., Ltd. in Haikou identified significant deficiencies in laboratory controls. The firm failed to establish scientifically sound sampling plans and test procedures for both process and cleaning validations. These lapses raise concerns about the assurance of drug product quality, purity, and the prevention of cross-contamination.

## Related Officers

- [Supervisory Consumer Safety Officer, China Office](https://www.keypedia.com/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)

Company: https://www.keypedia.com/companies/bright-future-pharmaceutical-hainan-co-ltd/79d349e9-51a9-48c3-84da-1e7f21853067

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1