FDA 483 - Smolek L & G Inc. - March 09, 2023

Smolek L & G Inc., an unlicensed feed mill in Idaville, IN, was cited for significant violations during an FDA inspection. The firm manufactured and distributed medicated animal feed containing VFD drugs without the required lawful Veterinary Feed Directives. Additionally, bulk shipments of medicated feed lacked adequate labeling, including VFD statements, feeding instructions, and withdrawal times, which could lead to animal health issues and tissue residues.