# FDA 483 - Yichang Humanwell Oral Solid Dosage Plant - June 24, 2019

Source: https://www.globalkeysolutions.net/records/483/yichang-humanwell-oral-solid-dosage-plant/7b89f861-104f-484b-8920-b3d42a1ee86b

> FDA 483 for Yichang Humanwell Oral Solid Dosage Plant on June 24, 2019. 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: 2019-06-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Yichang Humanwell Oral Solid Dosage in Yichan, Hubei, China, identified a significant deficiency in computer system controls. The firm failed to ensure that changes to master production and control records were instituted only by authorized personnel. This was evidenced by non-validated Excel worksheets used for production calculations being accessible and modifiable by unauthorized analysts, posing a risk to data integrity.

## Related Documents

- [483 - 2020-11-16](https://www.globalkeysolutions.net/records/483/yichang-humanwell-oral-solid-dosage-plant/27c0c01e-8b0d-41ff-9a62-c7579555edd8)

## Related Officers

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

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