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Hospira Inc.

Division of Pfizer Inc.
www.hospira.com

Latest From Hospira Inc.

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

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.

 

Manufacturing Quality

FDA Warns Lymol To Assess Talc Lead Risk Per ICH Q3D; Puts Others On Notice

A warning letter to firm with legacy talc drug product puts pharmaceutical industry on notice: the US FDA expects applicants to meet requirements agency imposes post-approval for matters like elemental impurities compliance.

Enforcement Quality

While There's No Easy Rx for Drug Shortages, Pharma Groups Have Some Ideas

Industry groups suggest that the drug shortage crisis needs to be addressed by changing the economic model for reimbursement, while US FDA can help by making it easier for manufacturers to use “standby” facilities as needed to bridge supply gaps and by providing generic drug manufacturers with more notice on when applications will be approved.

Manufacturing Quality

Pfizer Pulls Plug On Two Unviable Indian Sites, Over 1,500 Jobs At Risk

Pfizer is ending operations at two Indian manufacturing sites, including one with a checkered regulatory history. Approximately 1,700 jobs are at stake as a result of the action, though the US multinational clarified that it is not making a widespread exit from Indian manufacturing.
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