FDA WARNING_LETTER - Contract Coating, Inc.

The FDA issued a Warning Letter to Contract Coating Inc. on July 18, 2014, for failing to pay required facility fees under the Generic Drug User Fee Amendments of 2012 (GDUFA). Specifically, the company did not pay the annual facility fees for fiscal years 2013 and 2014, despite having self-identified for those periods. This non-compliance, as per 21 U.S.C. §§ 379j-41 to 379j-42, renders all finished dosage forms of drugs and active pharmaceutical ingredients (APIs) manufactured at the facility misbranded (21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A)(iii)). Shipping misbranded products in interstate commerce, including importation, is a violation of federal law (21 U.S.C. § 331(a)). As a consequence, Contract Coating Inc. has been placed on a publicly available GDUFA facility arrears list. The FDA warns that failure to promptly correct these violations by immediately paying the outstanding fees may lead to regulatory actions such as seizure, injunction, or import alerts, preventing drug admission into the U.S. Additionally, any generic drug submissions from the firm or its affiliates will not be received by the FDA. The company is required to notify the FDA in writing within 15 working days of the steps taken to correct the noted violations, and is advised to contact the Drug Shortages Program if considering production reductions.