Sharon Bio-Medicine Limited – FDA Warning Letter

This FDA Warning Letter, dated June 22, 2015, addresses Sharon Bio-Medicine Limited (FEI - 3005925733) in India for failing to pay required facility fees under the Generic Drug User Fee Amendments of 2012 (GDUFA).

The facility, identified in pending and/or approved generic drug submissions, failed to pay annual facility fees for fiscal years 2013, 2014, and 2015, despite self-identifying for these years. This non-payment renders all finished dosage forms of drugs or active pharmaceutical ingredients (APIs), and drugs containing APIs manufactured at the facility, as misbranded under 21 U.S.C. §§ 352(aa) and 379j-42(g)(4)(A)(iii).

Regulatory citations highlight that shipping misbranded products in interstate commerce, including importation into the U.S., is a violation of federal law (21 U.S.C. § 331(a)). Consequences include potential injunctions, seizures (21 U.S.C. §§ 332, 334), and denial of entry into the U.S. (21 U.S.C. § 381(a)(3)).

The facility has been placed on a publicly available GDUFA facility arrears