Vista Pharmaceuticals, Ltd. – FDA Warning Letter

This FDA Warning Letter, WL: GDUFA-15-021, dated June 22, 2015, was issued to Vista Pharmaceuticals Ltd. for failing to pay required facility fees under the Generic Drug User Fee Amendments of 2012 (GDUFA).

The facility, identified in pending/approved generic drug submissions, self-identified for fiscal years 2013, 2014, and 2015, but did not pay the corresponding annual facility fees due on March 4, 2013, October 18, 2013, and October 1, 2014, respectively.

As a result, all drugs or active pharmaceutical ingredients (APIs) manufactured at this 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 into the U.S., is a violation of federal law (21 U.S.C. § 331(a)).

The facility has been placed on a publicly available GDUFA facility arrears list. Consequences include potential injunctions, seizures of misbranded products, denial of entry into the U.S. for products, and non-receipt of new generic drug submissions referencing the facility or from the responsible person