# FDA 483 - MFCI (Huanggang) Co., Ltd. - August 14, 2017

Source: https://www.globalkeysolutions.net/records/483/mfci-huanggang-co-ltd/d7ddcda6-a90c-4edd-870b-b2b5047477c8

> FDA 483 for MFCI (Huanggang) Co., Ltd. on August 14, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MFCI (Huanggang) Co., Ltd.
- Inspection Date: 2017-08-14
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: The FDA inspection of MFCI (Huanggang) Co., Ltd. in Huanggang, Hubei, China, revealed significant data integrity issues, including deleted laboratory records and inadequate computer controls. Numerous deficiencies were also found in equipment maintenance, process validation, environmental controls, and quality control procedures for API manufacturing. These observations indicate a systemic lack of adherence to cGMP requirements, posing a risk to product quality and patient safety.

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)
- [Jose A. Cruz Gonzalez](https://www.globalkeysolutions.net/people/jose-a-cruz-gonzalez/a005cff1-0a90-4396-82c4-de4b0a579374)

Company: https://www.globalkeysolutions.net/companies/mfci-huanggang-co-ltd/73adbac1-641e-4e25-904c-9724b9848ac3

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