C.P.M. Contract Pharma GmbH & Co. KG – FDA Warning Letter, Jan 14, 2014

This FDA Warning Letter, GDUFA-13-001, dated September 17, 2013, was issued to C.P.M. Contract Pharma GmbH & Co. KG for failing to self-identify their facility and pay the required facility fees under the Generic Drug User Fee Amendments of 2012 (GDUFA).

The facility, identified as a finished dosage form manufacturer, failed to self-identify for fiscal years 2013 (due by December 3, 2012) and 2014 (due between May 1 and June 1, 2013), and did not pay the fiscal year 2013 facility fees (due March 4, 2013). These failures violate 21 U.S.C. §§ 379j-41-379j-42.

As a result, all drugs or active pharmaceutical ingredients manufactured at the facility are considered misbranded under 21 U.S.C. §§ 352(aa) and 379j-42(g)(4)(iii). Shipping misbranded products into U.S. interstate commerce is a violation of federal law (21 U.S.C. § 331(a)), potentially leading to injunctions, seizures (21 U.S.C. §§ 33