# FDA 483 - Hubei Meikai Chemical Co. Ltd - July 07, 2014

Source: https://www.keypedia.com/records/483/hubei-meikai-chemical-co-ltd/bef81ad5-30b8-4c31-bc06-455f0881a34c

> FDA 483 for Hubei Meikai Chemical Co. Ltd on July 07, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hubei Meikai Chemical Co. Ltd
- Inspection Date: 2014-07-07
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Hubei Meikai Chemical Co Ltd in Huanggang, P.R. China, an active pharmaceutical ingredient manufacturer, revealed significant deficiencies across its quality, laboratory, facility, and materials systems. The firm failed to adhere to its own procedures for internal audits and annual product reviews, and exhibited issues with laboratory controls, equipment calibration, and material identification. These observations indicate a lack of robust quality control and data integrity practices.

## Related Officers

- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.keypedia.com/companies/hubei-meikai-chemical-co-ltd/66b4b53d-0cce-41c4-8fe9-4939ff61602d

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321