Yunnan Hande Bio-Tech, 4/15

Yunnan Hande Bio-Tech, 4/15

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Warning Letter citation noting lab system security and audit trail issues.

Description

Yunnan Hande Bio-Tech, 4/15

Warning Letter contains observations concerning (1) failure to prevent deletion or alteration of lab data, and (2) lack of audit trails.

pa document category Warning Letter
Regulation Category Drug APIs – GMP
Date Published 2015
FDA Office CDER
System Category Laboratory
Citation Category Audit Trails, Security

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