Injectables and biosimilars giant Hospira, which was acquired by Pfizer in 2015, is making efforts to correct major violations and sterility issues at its Lrungattukottai, India plant that were called out in a 2013 Food and Drug Administration (FDA) warning letter, said Pfizer officials after a summer re-inspection of the plant by regulators from the U.K., Australia, the U.S., and Canada.
During the 2013 inspection that resulted in a warning letter, inspectors had identified major manufacturing violations including failing to properly clean surfaces and using damaged gloves when handling sterile products. Most concerning to inspectors is that those violations were similar to ones they had witnessed during an inspection at Hospira’s Rocky Mount, N.C., plant.
Regulators also said that the building itself was a contamination risk, for a number of reasons including a door into the vial-filling suite that allows unclean air to enter the room every time it is opened and two holes in the circulation area where sterile products are unloaded.
In 2013, the FDA also issued a warning letter to Hospira’s Lake Forest, Ill., plant over violations of good manufacturing practice standards that rendered some of its Class II medical devices adulterated.
Since then, Hospira has issued dozens of recalls on products including injectable solutions and infusion pumps over particulate matter observed in vials of solutions and manufacturing errors resulting in mislabeling. In 2016 alone, Hospira has issued four recalls on injectable solutions including anesthesia, magnesium sulfate and sodium bicarbonate.