FDA Warning Letter Slams Pfizer Site In India On Sterility Testing, 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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The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.
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.