FDA EIR - Nutritional Laboratories International Inc - June 25, 2013

An FDA inspection of Nutritional Laboratories International in Missoula, MT, was conducted on June 24-25, 2013. The inspection, performed under the Dietary Supplements - Import and Domestic regulatory framework (CP 7321.008A), focused on the company's manufacturing, storage, and distribution processes for dietary supplements. Although the report stated no deviations from Dietary Supplement Good Manufacturing Practices (GMPs), it highlighted minor operational deficiencies. These included a toilet tissue roll not properly dispensed in a restroom, a non-sanitizable brush used for in-process product powders, and improper storage of scoops on non-food contact surfaces alongside other items in a weigh room. Management promptly committed to correcting these observations. Despite these identified issues, a formal FDA 483 (Inspectional Observations) was not issued, and the inspection concluded with a "No Action Indicated" classification, indicating that no further regulatory actions were required from the FDA.