FDA WARNING_LETTER - Korea United Pharm - March 04, 2015

This FDA Warning Letter (WL: GDUFA-14-009) dated August 7, 2014, was issued to Dr. Seung-Ho An of Korea United Pharm Inc. for failing to pay required facility fees under the Generic Drug User Fee Amendments of 2012 (GDUFA).

The facility, identified in pending and/or approved generic drug submissions, failed to pay the annual facility fees for fiscal years 2013 (due March 4, 2013) and 2014 (due October 18, 2013). While the facility self-identified for both years, the fee payment was not made.

This non-payment renders all drugs or active pharmaceutical ingredients (APIs) manufactured, prepared, propagated, compounded, or processed at the facility, or drugs containing such APIs, as misbranded under 21 U.S.C. §§ 352(aa) and 379j-42(g)(4)(A)(iii). Shipping misbranded products in interstate commerce, including importation into the U.S., is a violation of federal law (21 U.S.C. § 331(a)).

Consequences include potential injunctions, seizures of misbranded products (21 U.S.C. §§ 332, 334), denial of entry into the U