FDA WARNING_LETTER - Jiangsu ZW Pharmaceuticals Co. Ltd.

This FDA Warning Letter, GDUFA-15-017, dated June 22, 2015, addresses Jiangsu ZW Pharmaceuticals Co. Ltd. for failing to comply with 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 required annual facility fees for fiscal years 2013, 2014, and 2015.

Under GDUFA, a facility engaged in manufacturing or processing active pharmaceutical ingredients (APIs) or finished dosage forms for generic drugs must self-identify annually and pay an annual facility fee. Failure to do so renders any drugs or APIs manufactured at the facility, or drugs containing such APIs, as misbranded under 21 U.S.C. §§ 352(aa), 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)), potentially leading to injunctions, seizures, or denial of entry into the U.S. (21 U.S.C. §§ 332, 334, 381(a)(3)).

The facility has been placed on a publicly available G