Pfizer temporarily shutters Indian facility after inspections
- Pfizer has temporarily shut down production at a generic drug manufacturing site near Chennai, India, reports The Economic Times.
- Acquired in Pfizer's acquisition of Hospira last year, the facility had previously been flagged by the U.S. Food and Drug Administration for a number of manufacturing violations in 2013.
- A team of four drug regulators, including the FDA and the U.K.'s Medicines and Healthcare Products Regulatory Agency, raised new concerns in a June inspection which led to the shutdown, The Economic Times said.
The FDA has stepped up its enforcement efforts in India, sending warning letters to 17 companies regarding violations at India-based facilities over the past 18 months.
A number of high-profile Indian drugmakers, including Sun Pharma, Dr. Reddy's and Cadila have been hit with the warnings, along with numerous smaller firms.
But multinational generic drugmakers haven't escaped the FDA's oversight either. Novartis' Sandoz unit, Mylan, Apotex and now Pfizer have all been cited for their Indian-based facilities.
Pfizer temporarily stopped production at its Irungattukottai site to allow inspections to proceed, according to Stat.
A Pfizer spokeswoman confirmed to BioPharma Dive that the company is working to resolve the issues at the site.
"Pfizer has formally responded to the inspection findings issued following the recent inspection of the legacy Hospira Irungattukottai, India site," the spokeswoman said. "The site is implementing actions to address the findings."
Even if temporary, the suspension is another headache tied to manufacturing lapses at Hospira plants. In 2013, FDA inspectors noted numerous issues at that same Irungattukottai facility related to how sterile materials were handled.
Last year, another Hospira plant in Italy was also cited by the FDA for manufacturing violations.
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