FDA EIR - Conklin Company, Inc. - May 10, 2017

An FDA inspection was conducted at Conklin Company, Inc., located in Shakopee, MN, on May 10, 2017. The inspection, performed by the Minnesota Department of Agriculture under federal contract for the FDA, aimed to assess the company's compliance with BSE Regulation 21 CFR 589.2000/589.2001. Conklin Company, Inc. guarantees livestock, companion animal, and human probiotic supplements marketed under the "Fastrack" brand. The facility also manufactures various other products like fertilizers, coatings, lubricants, and cleaners, and operates as a distribution warehouse for all its offerings. During the inspection, management was provided with FSMA Fact Sheets concerning Preventative Controls for Animal Food and Sanitary Transport rules. Crucially, no violations or adverse observations related to the BSE regulation were identified. Consequently, no FDA Form 483, which lists inspectional observations requiring corrective action, was issued, and no samples were collected. This outcome signifies that no specific regulatory actions were mandated for the company following this inspection, consistent with the findings of their previous inspection in 2015.