FDA WARNING_LETTER - Wuxi Kaili Pharmaceutical Company LTD.

The FDA issued a Warning Letter (WL: GDUFA-15-022) to Wuxi Kaili Pharmaceutical Company LTD. on June 22, 2015, for non-compliance with the Generic Drug User Fee Amendments of 2012 (GDUFA). The primary violation identified is the company's failure to pay the required annual facility fees for fiscal years 2013, 2014, and 2015, despite having self-identified for these periods. Under GDUFA (21 U.S.C. §§ 379j-41 to 379j-42), facilities manufacturing active pharmaceutical ingredients or finished dosage forms for generic drug submissions must pay these fees. Consequently, all finished dosage forms and APIs manufactured at Wuxi Kaili are deemed misbranded, a violation of 21 U.S.C. §§ 352(aa) and 379j-42(g)(4)(A)(iii). Shipping misbranded products into U.S. interstate commerce is prohibited by 21 U.S.C. § 331(a). As a result of this non-payment, the facility has been placed on a publicly available GDUFA facility arrears list. This means any generic drug submissions from Wuxi Kaili or its affiliates will not be received by the FDA, and new submissions referencing the facility will also be rejected if fees remain unpaid. The FDA requires immediate payment of all outstanding fees for 2013, 2014, and 2015. Failure to promptly correct these violations may lead to further regulatory actions, including seizure, injunction, or placement on import alert, preventing their drugs from entering the United States. A written response detailing corrective actions is required within 15 working days.