Antibioticos, S.A. – FDA Warning Letter

This FDA Warning Letter, dated June 2, 2014, addresses Antibioticos, S.A. (FEI- 3002806372) in Leon, Spain, for non-compliance with the Generic Drug User Fee Amendments of 2012 (GDUFA). The facility failed to self-identify for fiscal year 2014 and did not pay the required facility fees for fiscal years 2013 and 2014.

Under GDUFA, facilities engaged in manufacturing or processing active pharmaceutical ingredients (APIs) or finished dosage forms, identified in pending or approved generic drug submissions, must self-identify annually and pay an annual facility fee. Self-identification for FY2013 was due by December 3, 2012, and for FY2014 between May 1, 2013, and June 1, 2013. Fees for FY2013 were due March 4, 2013, and for FY2014 on October 18, 2013.

As a result of these violations, all drugs or APIs manufactured at the facility, and drugs containing APIs from the facility, are considered misbranded under 21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A