Pfizer was well aware that a Hospira plant in India had a history of issues when it acquired the sterile injectable drug maker last year for $15 billion. The Pharma giant indicated that with its expertise, it could get a handle on that. But a new report shows international regulators were unimpressed with Pfizer’s operations there during a recent inspection.
Pfizer ($PFE) earlier this month acknowledged it had suspended manufacturing at its Hospira plant in Irungattukottai in Chennai, India, following the re-inspection by regulators from the U.S., U.K., Canada and Australia. Pfizer, however, offered no explanation of what had concerned the visitors.
But the plant’s issues were detailed in a report filed today with the European Medicines Agency by England’s Medicines and Healthcare Products Regulatory Agency (MHRA). It says the inspection uncovered a variety of critical issues that put into question an assurance that the injectable products coming out of the facility are sterile.
Inspectors found that employees were using aseptic processes that could allow for microbial contamination, and that Pfizer’s investigations into issues were not getting to root causes of problems. It said all of the all of the plant’s shortcomings were linked to employees who lacked the “scientific knowledge” to know what to do.
Pfizer has already said that it has responded to regulators' concerns and is implementing a “holistic plan” to fix the problems.
But in the meantime, the U.K. said it was pulling the plant’s GMP certificate and halting its imports to the European Union of 6 injected antibiotics in 19 total dose forms until it is satisfied that Pfizer has changed the procedures that could lead to contamination. Among the products banned from the EU were Piperacillin/Tazobactam and Cefuroxime.
The plant was first cited with an FDA warning letter three years ago, well ahead of Pfizer’s decision last year to buy Hospira. The FDA also raised doubts about the company’s ability to ensure sterile drugs and ordered Hospira to create a "global corrective action plan" for both its foreign and U.S. plants, including how it intends to train employees involved in aseptic processes, which Hospira has said it was doing.
Pfizer bought the biosims- and generics-focused Hospira for $15 billion last year to round out its generics manufacturing offerings and despite regulatory concerns, the deal is already paying back Pfizer’s investment. Earlier this month, the drugmaker cited the unit for helping drive an analyst-beating 11% revenue jump to $13.15 billion in Q2.
- access the report here
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