FDA Warns NJ Drug Coating Company for Not Paying GDUFA Fees

A New Jersey drug coating company hasn’t paid its generic drug facilities fees for the last two fiscal years, making every product it helps to manufacture automatically mislabeled, the FDA warned.

Because of its failure to pay the GDUFA fees, drugs prepared by Hackensack, N.J.-based Contract Coating are misbranded and illegal to ship in interstate commerce, the FDA said in a July 18 warning letter. The products are liable to injunctions and seizures, it added.

All told, the FDA lists 35 manufacturers as owing GDUFA fees for FY2014 as of Aug. 1. Failure to pay outstanding fees within 20 days of notice from the FDA will halt acceptance of any new ANDA submission, the agency said.

Contract Coating did not return a request for comment by press time.

Fees owed by GDUFA facilities depend on whether they produce a finished product or the active pharmaceutical ingredient. For finished product makers, the FY2014 fee for any domestic U.S. facility listed in an ANDA was $220,152. For domestic facilities that make the API, the fee was $34,515.

The FDA identifies Contract Coating as a final product maker on its list of facilities that have not paid their GDUFA fees. That makes the company liable for the $220,152 fee. On its website, Contract Coating says it provides drug coating for a variety of products and touts its compliance with current good manufacturing practice.

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