Explora Laboratories – FDA Warning Letter, Aug 7, 2014

On August 7, 2014, the FDA issued a Warning Letter to Explora Laboratories SA for failing to pay required facility fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) for fiscal years 2013 and 2014.

Explora Laboratories, identified in a pending and/or approved generic drug submission, is a drug manufacturing facility subject to GDUFA requirements. While the facility self-identified for both fiscal years, it did not pay the annual facility fees due on March 4, 2013 (FY2013) and October 18, 2013 (FY2014).

Failure to pay these fees renders all finished dosage forms of drugs or active pharmaceutical ingredients (APIs) manufactured at the facility, or drugs containing an API from the facility, 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 of this violation include potential injunctions, seizures of misbranded products, denial of entry into the U.S. for products, and placement on a publicly available GDUFA facility arrears list