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USFDA issues import alert on Hospira's Chennai plant

Press Trust of India  |  Hyderabad 

The USFDA has imposed Import Alert on the drugs being manufactured at a facility owned by Healthcare India, a company, in after the regulator found lapses with regard to good practice (CGMP) regulations during an inspection.

"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, may withhold approval of any new applications or supplements listing your firm as a manufacturer," said in a letter to the maker.

The US Food and 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 until the data integrity issues are thoroughly investigated," the regulator said.

The multinational pharma earlier in January said it planned to shut down its 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 in 2015.

The methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, and the manufactured are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 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 manufactured at the plant into the United States, it added.

The manufactures generic injectable cephalosporin, penems, and penicillin for the US, EU and rest of the world markets.

It also produces branded

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, March 14 2019. 15:10 IST