The alert was imposed after the regulator found lapses with regard to good manufacturing practice (CGMP) regulations
The USFDA has imposed import alert on the drugs being manufactured at a facility owned by Hospira Healthcare India, a Pfizer company, in Tamil Nadu after the regulator found lapses with regard to good manufacturing practice (CGMP) regulations during an inspection. “FDA placed your firm on Import Alert 66-40 on August 1, 2018. Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” FDA said in a letter to the drug maker.
The US Food and Drug Aadministration (USFDA) conducted inspection from March 27 to April 3, 2018. “The critical data integrity breaches identified in our inspection also raise serious concerns regarding the validity of all results reported by your quality control laboratory. We acknowledge your decision during the inspection to suspend release of drug products until the data integrity issues are thoroughly investigated,” the regulator said.
The multinational pharma major earlier in January said it planned to shut down its manufacturing units in Chennai and Aurangabad in the current fiscal due to “very significant long-term loss of product demand.” The plants had been part of its acquisition of US-based Hospira in 2015.
The methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, and the drug products manufactured are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC 351(a)(2)(B), the FDA said in its warning letter. Failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at the plant into the United States, it added. The Irungattukottaiplant manufactures generic injectable cephalosporin, penems, and penicillin for the US, EU and rest of the world markets. It also produces branded Maxipime.