When Pfizer received a warning letter for an older, Hospira sterile injectables plant in India last year, it was not seen as a big deal in the market. The company had already closed the long-troubled plant and still had the 1.1-million-square-foot, $450 million injectables plant in Visakhapatnam. But now that plant is in trouble with the FDA.
The FDA Tuesday posted a warning letter that thrashed the company’s Vizag plant 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.
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In an emailed statement, Pfizer today said that the Vizag plant is “a modern, sterile injectable facility” and that the company is committed to ensuring the safety and quality of the drugs produced there. It said it has a comprehensive plant in place to address FDA’s concerns.
“We know that people—including our own families—count on them to be safe and effective,” the statement reads. “We settle for nothing less.”
Except, the FDA says the plant was settling for less and the plant’s quality system was not ensuring the "safety, effectiveness and quality of the sterile drugs” it being shipping to the U.S.
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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.
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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.
Pfizer last year actually closed two India plants with a combined 1,700 workers. Both were picked up in its $15 billion buyout of Hospira in 2015. The U.S. pharma shut down the long-troubled injectables facility in Irungattukottai, India, as well as another site in Aurangabad, India. Pfizer said at the time, that the closures were due to a fall in demand for the products the plants’ produced and unrelated to the FDA issues.
Pfizer has a sterile drug plant in Kansas which previously was warned by the FDA.