FDA WARNING_LETTER - Andapharm, LLC - October 10, 2014

The FDA issued a Warning Letter to Andapharm, LLC for non-compliance with the Generic Drug User Fee Amendments of 2012 (GDUFA). The facility failed to pay the required annual facility fees for fiscal years 2013 and 2014, despite self-identifying. Under GDUFA (21 U.S.C. §§ 379j-41 to 379j-42), facilities manufacturing generic drug APIs or finished dosage forms must pay annual fees. As a result of the unpaid fees, all drugs and APIs manufactured by Andapharm, LLC are considered misbranded, violating 21 U.S.C. §§ 352(aa) and 379j-42(g)(4)(A)(iii). Shipping these misbranded products in interstate commerce, including importation, is a violation of federal law (21 U.S.C. § 331(a)). The facility has been placed on a publicly available GDUFA facility arrears list. Andapharm is required to immediately pay the outstanding 2013 and 2014 fees and respond within 15 working days with corrective actions. Failure to comply could lead to regulatory actions such as seizure, injunction, import alerts, and non-receipt of future generic drug submissions. The firm was also advised to contact the Drug Shortages Program if considering production reductions.