FDA WARNING_LETTER - Calaire Chimie S.A.S.

This FDA Warning Letter, dated July 18, 2014, was issued to Calaire Chimie S.A.S. 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 fiscal year 2013 and 2014 facility fees, due March 4, 2013, and October 18, 2013, respectively. Additionally, while the facility self-identified for 2013, it failed to self-identify for 2014, which was required between May 1, 2013, and June 1, 2013.

As a result of these violations, all drugs or active pharmaceutical ingredients (APIs) manufactured at the facility are considered 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)) and can lead to injunctions, seizures, or denial of entry into the U.S. (21 U.S.C. §§ 332,