483
Yichang Humanwell Oral Solid Dosage PlantYichang Humanwell Oral Solid Dosage Plant – FDA 483, Jun 24, 2019
Record Details
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.
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ID · 7b89f861-104f-484b-8920-b3d42a1ee86b
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