# FDA 483 - Yichang Humanwell Oral Solid Dosage Plant - November 16, 2020

Source: https://www.globalkeysolutions.net/records/483/yichang-humanwell-oral-solid-dosage-plant/27c0c01e-8b0d-41ff-9a62-c7579555edd8

> FDA 483 for Yichang Humanwell Oral Solid Dosage Plant on November 16, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yichang Humanwell Oral Solid Dosage Plant
- Inspection Date: 2020-11-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspected Yichang Humanwell Oral Solid Dosage Plant in Yichang, Hubei, China, and issued a Form 483 with two observations. The inspection revealed deficiencies in batch production and control records, specifically regarding the inclusion of in-process results. Additionally, laboratory controls were found to be inadequate, lacking scientifically sound and appropriate test procedures to ensure drug product quality.

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## Related Officers

- [Marijo B. Kambere](https://www.globalkeysolutions.net/people/marijo-b-kambere/54e010f0-0d56-4b20-b5e2-112e372de58b)

Company: https://www.globalkeysolutions.net/companies/yichang-humanwell-oral-solid-dosage-plant/5757d69c-083b-427c-8ee0-a2aa0b6b11c4

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