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

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.