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Pfizer Must Correct Data Integrity Problems Seen At India Plant Globally, FDA Says

 
• By Joanne S. Eglovitch

US FDA warning letter instructed Pfizer to implement a global corrective and preventive action plan to address widespread data integrity problems. While the impact of the warning letter on the site is expected to be minimal due to its closure, the global impact on the company’s sterile drug operations could be significant.  

Warning Rubber Stamp

Pfizer Inc.’s sterile injectables operation was dealt another blow after receiving a US FDA warning letter telling the company to develop a global corrective and prevention plan to address the type of data integrity problems found at a site in India that the firm acquired from

Hospira Inc. in 2015.

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