Setback for Pfizer, US FDA issues warning letter to company's Vizag plant

Pharmaceutical major Pfizer has been issued a warning letter by US FDA on issues of failed sterility test, Environmental Monitoring Program and data integrity remediation issues. US FDA warning letter was issued on March 25, against the Vishakhapattanam plant of the company. The plant manufactures injectible products. 

US FDA officials inspected the plant between August 29-September 6. US FDA in its warning letter to company on issues of failed sterility test noted that  ” Your firm failed to conduct adequate investigations, including timely implementation of effective corrective action and preventive action (CAPA) plans. The timeliness of the CAPA to resolve these significant root causes was insufficient.” It further added “You did not adequately investigate root causes and implement CAPA to address deficiencies regarding your sterility testing.” 

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On the issue of Environmental Monitoring Program the Warning letter said ”You did not adequately investigate serious deficiencies in microbiology laboratory conditions and practices. Among the deficiencies were excessive occurrences of negative control plate contamination, high levels of contamination in environmental monitoring samples of the sterility test”.  

US FDA also said in warning letter that “You are improving overall laboratory capabilities and investigations systems. However, your response did not fully address how deficient laboratory controls, inadequate investigations, and delays in implementing CAPA compromised your firm’s microbiological control program”. 

US FDA has asked the company to provide revised investigations regarding the sterility failure and the loss of environment control in the sterility testing. 

On the issue of Data Integrity Remediation the US FDA observed that “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.

It further warned: “Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer. Failure to correct these violations may also result in the FDA refusing admission of articles manufactured at Pfizer Healthcare India Private Limited”. 

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In an e-mail response to the query by Zee Business, Pfizer replied” We have a comprehensive plan in place to address the concerns raised by the FDA. Pfizer’s Vizag site is a modern, sterile injectable facility providing high quality critical medicines to hospitals. We are committed to ensuring the safety and quality of our medicines, and we stand behind all products manufactured at the Vizag site. Nothing is more important to Pfizer than the quality and safety of our medicines.”