FDA EIR - Conklin Company, Inc. - May 28, 2015

An FDA surveillance inspection of Conklin Company, Inc., located in Shakopee, MN, was conducted on May 28, 2015. The purpose of this inspection was to determine the company's compliance with federal regulations, specifically 21 CFR 225 (Current Good Manufacturing Practice for Medicated Feeds), 21 CFR 589.2000 (Animal proteins prohibited in ruminant feed), and 21 CFR 589.2001 (Animal materials prohibited in animal feed), which include guidelines for Bovine Spongiform Encephalopathy (BSE) prevention. Conklin Company, Inc. guarantees and distributes livestock, companion animal, and human probiotic supplements under the "Fastrack" brand, and also manufactures other products at this site. The company outsources the manufacturing of its probiotic supplements. The inspector reviewed relevant records, observed facility conditions, and examined products during the inspection. Crucially, the inspection found no adverse observations, objectionable conditions, or violations related to the specified regulations. Consequently, no FDA Form 483, which would indicate observations of non-compliance, was issued. As no violations were identified, no specific corrective actions were required from Conklin Company, Inc. The company's Director of Operations was provided with informational materials regarding food facility registration, food defense preparedness, and user fees.