YERUSHALAYIM - Teva has received a warning letter from the FDA [U.S. Federal Drug Administration] – its second in six months – raising concerns over its compliance with the agency’s “good manufacturing practices.” The concerns revolve around a visit by FDA inspectors to a manufacturing plant operated by Teva in China that took place last September. Teva has until May 1 to respond to the letter.
The letter points out what the FDA said were problems with the inspection of samples of the products produced in the plant before they were passed on to other Teva facilities for manufacture. Teva said in a regulatory filing that it complied with the highest standards demanded by the FDA, and that any issues raised by the FDA had already been corrected.
In October 2016, Teva received a warning letter over similar concerns after inspectors visited a Teva plant in Hungary. That visit was a followup to a previous one in January of that year, after which the agency slapped a ban on products manufactured in the plant imported into the United States.