FDA WARNING_LETTER - Marck Biosciences Ltd. - August 26, 2014

The FDA issued a Warning Letter to Marck Biosciences Ltd. on August 26, 2014, due to the facility's failure to pay required Generic Drug User Fee Amendments (GDUFA) facility fees for fiscal years 2013 and 2014. The facility, located in Hariyala Kheda, Gujarat, India, is a drug manufacturing facility identified in pending and/or approved generic drug submissions.

While Marck Biosciences Ltd. self-identified for both 2013 and 2014, it did not pay the associated annual facility fees, which were due on March 4, 2013, and October 18, 2013, respectively. This non-payment renders all finished dosage forms of drugs or active pharmaceutical ingredients (APIs), as well as drugs containing an API, manufactured at the facility, as 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. § 331(a)). Consequences for such violations can include injunctions, seizures of misbranded products, and denial of entry into the U.S. (21 U.S.C. §§