FDA EIR - Dean's Zesty Beverages LLC - January 10, 2020

An FDA inspection of Barretts Minerals, Inc., a manufacturer of USP talc used in food and cosmetic products, was conducted from January 9-10, 2020, at their Dillon, MT facility. The inspection was performed under the Compliance Program 7329.001, focusing on Colors and Cosmetics Technology. The primary outcome of this inspection was positive, as no objectionable conditions were found, and no Form FDA 483 (Inspectional Observations) was issued to the firm. This indicates full compliance with regulatory requirements during the inspection period. Furthermore, the report confirmed that all six discussion items raised during the previous FDA inspection in February 2015 were verified as corrected. These prior items had included concerns regarding documentation for certificates of analysis, raw material testing, preventative maintenance records, process validation procedures, prevention of cross-contamination in sterilizers, and adherence to procedures for stability study samples. Since no issues were identified or discussed during the current inspection, Barretts Minerals, Inc. is not required to take any further corrective actions as a result of this specific assessment. The company maintains its registration as both a food and drug manufacturer.