OrgSyn Laboratory Inc – FDA Warning Letter, Aug 26, 2014

This FDA Warning Letter (WL: GDUFA-14-012) dated August 26, 2014, was issued to Mr. Mahendra Deshpande of OrgSyn Laboratory Inc. (FEI - 3006725670) for failing to pay required facility fees under the Generic Drug User Fee Amendments of 2012 (GDUFA).

OrgSyn Laboratory Inc. is identified as a drug manufacturing facility engaged in manufacturing or processing active pharmaceutical ingredients (APIs) or finished dosage forms. The facility self-identified for fiscal years 2013 and 2014, as required by GDUFA, but failed to pay the annual facility fees due on March 4, 2013 (for FY2013) and October 18, 2013 (for FY2014).

As a result of this non-payment, all drugs or APIs manufactured, prepared, propagated, compounded, or processed at OrgSyn Laboratory Inc., or drugs containing APIs from this facility, are considered misbranded under 21 U.S.C. §§ 352(aa) and 379j-42(g)(4)(A)(iii). Shipping misbranded products in interstate commerce, including importation into the U.S., is a violation of federal law (21 U.S.C.