FDA WARNING_LETTER - Fleming Laboratories Ltd. - January 15, 2017

This FDA Warning Letter, dated August 26, 2014, addresses Fleming Laboratories Limited for failing to pay required facility fees under the Generic Drug User Fee Amendments of 2012 (GDUFA). The facility, located in Shivampet Mandal, India, is a drug manufacturing facility identified in pending and/or approved generic drug submissions.

The core violation is the failure to pay the annual facility fees for fiscal year 2014, as mandated by 21 U.S.C. §§ 379j-41 to 379j-42. While the facility self-identified for 2013 and 2014, the 2014 fees were not paid. This renders all finished dosage forms of drugs or active pharmaceutical ingredients (APIs), and drugs containing an API, manufactured at the facility as misbranded, per 21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A)(iii).

Regulatory implications include the facility being placed on a publicly available GDUFA facility arrears list. Furthermore, any generic drug submission from Fleming Laboratories or its affiliates will not be received by the FDA. New generic drug submissions referencing this facility will also not be received if the outstanding fee isn't paid within 20 calendar days of notification.

Required corrective action is the immediate payment of fiscal