More than a year after spending roughly $17 billion to acquire Hospira, Pfizer is finding that curing the manufacturing woes at the company is not going to be easy. The big drug maker recently halted production at a plant near Chennai, India, after inspectors from several regulatory agencies, including the US Food and Drug Administration, found various quality control problems.
During an inspection last June, the agencies decided that the facility, which makes injectable drugs, deviated from good manufacturing practices, a standard benchmark for safe production. A Pfizer spokeswoman wrote that no safety issues were reported with any medicines distributed from the site and that a “holistic plan” is being developed. But she did not offer a timetable for resuming production.
“At the time of the inspection, Pfizer temporarily paused production at the site to allow an assessment of observations by appropriate experts,” she explained. “Pfizer has not identified any issue that has an impact on marketed products … The site is fully engaged and is working toward resuming production as soon as possible.” The infractions were first reported by The Economic Times.