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Regulatory Focus™ > News Articles > 2020 > 3 > FDA Warns Pfizer Manufacturing Site in India

FDA Warns Pfizer Manufacturing Site in India

Posted 31 March 2020 | By Zachary Brennan 

FDA Warns Pfizer Manufacturing Site in India

Following an inspection last August and September, the US Food and Drug Administration (FDA) sent a warning letter to Pfizer’s injectable product manufacturing site in Visakhapatnam, India.

The letter, dated 25 March and released Tuesday, explains how the site did not adequately investigate root causes and implement corrective and preventive action (CAPA) to address deficiencies with its sterility testing.

FDA also notes microbial contamination and how the site “did not adequately investigate serious deficiencies in microbiology laboratory conditions and practices.”
 
In addition, the site invalidated microbial results without adequate scientific justification. 

“Between September 26 and December 23, 2018, your biological quality laboratory allowed EM [environmental monitoring] and testing plates used for monitoring your facility to be incubated beyond the days established in procedures. You attributed this recurring issue to a lack of qualified personnel,” FDA said.
 
In a follow-up on the warning, FDA is asking Pfizer to provide an assessment and remediation plan for its CAPA program, a complete assessment of documentation systems used throughout the site’s manufacturing and laboratory operations and more.
 
Other Warning Letters
 
In addition to Pfizer’s site, FDA also recently sent a warning letter to Bulgaria-based Ficosota after the firm’s manufacturing site lacked identity and strength testing for each batch of its over-the-counter (OTC) finished drug product.

FDA, following its inspection last September, said the site also failed to adequately test its incoming raw materials, including active pharmaceutical ingredients and other components, for identity, purity, strength and quality. 
 
Meanwhile, two websites unlawfully marketing unapproved and misbranded products to treat the coronavirus disease (COVID-19) also received warning letters recently. Both sites have 48 hours to respond to FDA. Other websites offering similarly deceptive and unapproved treatments also have received warning letters.

Warning Letter for Pfizer

Warning Letter for Ficosota

Unapproved and misbranded products related to COVID-19 Warning Letter

Unapproved and misbranded products related to COVID-19 Warning Letter

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