FDA WARNING_LETTER - Laboratorios Senosiain SA de CV - March 04, 2015

The FDA issued a Warning Letter to Laboratorios Senosiain S.A. de C.V. on August 26, 2014, due to the facility's failure to pay required annual facility fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) for fiscal years 2013 and 2014.

The facility, identified in pending and/or approved generic drug submissions, self-identified for both years but did not pay the associated fees, which were due March 4, 2013, and October 18, 2013, respectively. This non-payment renders all finished dosage forms and active pharmaceutical ingredients (APIs) manufactured at the facility, or drugs containing such APIs, as misbranded under 21 U.S.C. §§ 352(aa) and 379j-42(g)(4)(A)(iii).

Consequences of this violation include the facility being placed on a public GDUFA facility arrears list. Furthermore, any generic drug submission from Laboratorios Senosiain or its affiliates will not be received by the FDA. New generic drug submissions referencing this facility will also not be received unless the outstanding fees are paid within 20 calendar days of notification to the sponsor.

The FDA warned that failure to promptly correct these violations by paying the outstanding fees could lead to regulatory actions such as seizure