Pfizer Inc. (NYSE:PFE) has temporarily closed down a production plant near Chennai, India, after regulators found various quality control problems. The inspection was led by UK’s Medicine and Healthcare products Regulatory Agency and included, Health Canada, Therapeutic Goods Administration of Australia and US FDA. Pfizer noted that its temporary shutdown of the plant is being utilized to review the observations and develop holistic improvement plans and provide additional training to the production team at the site. It also noted that its colleagues were working towards resuming production as soon as possible.
The shutdown plant had belonged to Hospira before Pfizer spent about $17 billion to acquire the company. Since this acquisition, Pfizer has had to handle various regulators’ concerns about this plant and other plants that belonged to Hospira. During an inspection last June, the agencies decided that the facility near Chennai, which makes injectable drugs, deviated from good manufacturing practice. During that time Pfizer temporarily stopped production at the site to allow assessment of observation by appropriate experts. The same facility was in 2013 received an FDA warning letter.
Other Pfizer’s Hospira units, which sell a variety of injectable and infused drugs in The United States, Australia, Europe and Asia have experienced various production gaffes and subsequently issued dozens of product recalls. The long-running problems cast concerns about the company, though not enough to dissuade Pfizer. This is because Hospira has been one of the largest manufacturers of generic injectable medicine, which can help further Pfizer’s ambition to be a major player in both biosimilarsand the expansive market.
Vince Suneja, an attorney who advises drug makers on international markets noted that the extent of the current problem is difficult to ascertain since the inspection report is not posted on the agencies’ websites. He further pointed out that it depends on whether the same issues thatare raised during this review, are the same as those in 2013 investigation or whether there are other material observations.