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FDA Warning Letter Slams Pfizer Site In India On Sterility Testing, Environmental Monitoring

 
• By Joanne S. Eglovitch

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.

Warning Rubber Stamp
FDA Warning Letter Faults Pfizer's Sterility Testing, Lab Controls • Source: Shutterstock

The US Food and Drug Administration’s recent warning letter to a Pfizer Inc. site in Vizag, India, signals that the quality problems the company acquired along with Hospira’s sterile injectables business are not going away anytime soon.

The site was chastised for using manual visual inspection methods instead of automated methods for examining products and for “serious...

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