FDA WARNING_LETTER - Syntho Pharmaceuticals, Inc. - September 10, 2015

This FDA Warning Letter, WL: GDUFA-15-020, dated June 22, 2015, was issued to Syntho Pharmaceuticals 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 self-identify and pay annual facility fees for fiscal years 2013, 2014, and 2015.

According to GDUFA, a facility engaged in manufacturing or processing active pharmaceutical ingredients or finished dosage forms, and identified in a generic drug submission, must self-identify annually and pay an annual facility fee. Syntho Pharmaceuticals, Inc. did not meet these requirements for the specified fiscal years.

As a result, all drugs or active pharmaceutical ingredients manufactured, prepared, propagated, compounded, or processed at the facility are considered misbranded under 21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A)(iii). Shipping misbranded products in interstate commerce, including importation, is a violation of federal law (21 U.S.C. § 331(a)), potentially leading to injunctions, seizures, or denial of entry into the U.S.

The facility has been placed on a publicly available GDUFA facility arrears list.