FDA Issued a Warning Letter to the Pfizer Plant in India

| By | FDA, Sterility
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The FDA March 25 posted a warning letter that thrashed the company’s Vizag plant (the most modern sterile injectables plant that Pfizer acquired in its 2015 buyout of Hospira) for three issues that questioned the plant’s methods for ensuring the sterility of the injectable drugs, including an issue that it had been noted in a 2018 inspection. The letter followed an inspection of the plant last fall.

For one, the FDA said the facility did not even have an adequate method for testing sterility, relying on visual inspection instead of using an automatic test. Pfizer told the agency that it would add an automatic test, but not until July 2020, without explaining the reason for the delay. That was way too long for the FDA’s comfort.

“The timeliness of the CAPA to resolve these significant root causes was insufficient,” the FDA said.

Additionally, the FDA said the plant was not adequately investigating “serious deficiencies in microbiology laboratory conditions and practices.” Among other things, there were high levels of contamination in environmental monitoring and the lab was not thoroughly investigating “negative environmental trends,” the letter says.

The plant invalidated microbial results without adequate scientific justification and blamed poor monitoring on a lack of qualified workers. The letter also points out that Pfizer’s own investigation “discusses the commingling of media plates in the same bag that were overgrown to the point that one plate may have contaminated another plate.”

The FDA says it had pointed out these kinds of lapses in laboratory data accuracy during a September 2018 inspection.

The agency ordered Pfizer to provide it with a comprehensive investigation into the extent of the inaccuracies in data records and reporting and to report back with what risks those failings pose to the drugs on the U.S. market.

SOURCE: fiercepharma.com
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