Generic Drug Maker Apotex Warned by FDA for the Second Time

<"">Generic drug maker Apotex has been issued yet another Food & Drug Administration (FDA) warning letter over conditions at one of its manufacturing plant. The letter states that Canada-based Apotex shouldn’t be allowed to win approval for new generic drugs or send products to the U.S. until it corrects “significant violations” of good manufacturing practice at the Toronto facility.

According to a report in The New York Times, the letter lists a number of problems at the plant, including charred particles in a diabetes drug; contamination of an antihistamine, and drug cross-contamination that resulted from inadequate cleaning of manufacturing equipment. The letter, dated March 29, also said Apotex failed to notify regulators in a timely fashion about such problems. The problems were found during an inspection of the facility last summer.

This is the second time in the past year that the FDA has issued Apotex a warning letter over conditions at one of its manufacturing plants, the Times said. This past June, the agency warned the company about similar issues at its Etobicoke, Ontario facility.

In the most recent warning letter, the FDA wrote that the discovery of identical violations at both plants “demonstrate a lack of adequate process controls and raise serious questions regarding your corporation’s quality and production systems.”

Since last August, neither Apotex facility has been allowed to ship drugs to the U.S., however other facilities operated by the company can still do so.

Apotex was the eighth-largest provider of generics in the U.S. last year, according to the New York Times, quoting industry research firm IMS Health. American sales totaled $879 million last year, with 94 million prescriptions filled with the company’s medicines. The company produces 300 kinds of generic drugs.

Manufacturing issues at Apotex have caused other problems with U.S. regulators in the past. According to the Times, such issues prompted the firm to recall 659 batches of various drugs in the U.S. between July 2007 to August 2009.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.