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Data Integrity Lapses Continue To Erode Wockhardt

 
• By Anju Ghangurde

Details in US FDA’s latest warning letter for Indian site suggest that firm’s data integrity remediation efforts are not up to scratch at least yet. Agency’s observations also highlight the potential complexities that may be on hand for Cempra’s antibiotic Solithera, recently hit by a complete response letter.

Data Integrity

Wockhardt Ltd. has begun the new year on a disappointing note after a US FDA warning letter referred to a range of current good manufacturing practice (CGMP) violations at the firm’s Ankleshwar site in India, including those around data integrity.

The active pharmaceutical ingredient (API) unit in Ankleshwar has been under an FDA import alert since August 2016 and more recently in the news after Cempra Inc. indicated that...

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More from Compliance

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

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