FDA WARNING_LETTER - Microtest Laboratories, Inc. - September 18, 2014

This FDA Warning Letter (WL: GDUFA-14-013) dated August 26, 2014, was issued to Microtest Laboratories, Inc. 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, failed to pay annual facility fees for fiscal years 2013 (due March 4, 2013) and 2014 (due October 18, 2013), despite self-identifying for both years. This violation renders all finished dosage forms of drugs, active pharmaceutical ingredients (APIs), and drugs containing APIs manufactured at the facility as misbranded, per 21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A)(iii).

Regulatory citations include 21 U.S.C. §§ 379j-41 to 379j-42, which define facility and fee requirements. Shipping misbranded products in interstate commerce, including importation, is a violation of federal law (21 U.S.C. § 331(a)).

Consequences include placement on a public GDUFA facility arrears list, potential denial of receipt for new generic drug submissions referencing the facility, injunctions, seizures