Pfizer India Site Slammed By FDA
Warning Letter Criticizes Sterility Testing And Environmental Monitoring
Pfizer's third US FDA warning letter since 2018 goes to injectables site in Vizag, India; tells the company to up its game in sterility testing and in the microbiology lab.
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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.
Pfizer is set to close two of its manufacturing facilities in India this year, after the firm concluded that production at the former Hospira sites “is not viable” due to falling demand.
Problems persist at Pfizer’s US manufacturing facility in McPherson, Kansas, after an FDA audit led the agency to issue a ‘Form 483’ report with eight observations, seven of which were repeated from inspections dating back to as far as 2012.