FDA WARNING_LETTER - American Antibiotics, Inc. - July 23, 2014

On June 2, 2014, the FDA issued a Warning Letter to American Antibiotics, 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 fees for fiscal years 2013 and 2014, due on March 4, 2013, and October 18, 2013, respectively. While the facility self-identified for both years, the non-payment of fees renders all finished dosage forms of drugs or active pharmaceutical ingredients (APIs) manufactured there, as well as 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, is a violation of federal law (21 U.S.C. § 331(a)), potentially leading to injunctions, seizures (21 U.S.C. §§ 332, 334), or denial of entry into the U.S. (21 U.S.C. § 381(a)(3)). American Antibiotics, Inc. has been placed on a public GDUFA facility arrears list. Consequently