Xian Libang Pharmaceutical, 1/10

Xian Libang Pharmaceutical, 1/10

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Warning Letter requesting details of the configuration, qualification approach, and procedures for a system referenced in an earlier audit response.

Description

Xian Libang Pharmaceutical, 1/10

This Warning Letter includes a declaration from the FDA that the company’s response regarding correction of data manipulation practices was inadequate because it failed to completely address how the company would ensure the integrity of raw analytical data. The FDA requested a description of the configuration for the system that the company committed to purchase and install. They also requested the associated new or revised procedures and planned approach to qualify the system.

pa document category Warning Letter
Regulation Category Drugs – GMP
FDA Office CDER
System Category Laboratory
Citation Category Data Integrity, Documentation, Validation

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