FDA EIR - Nutritional Laboratories International Inc - August 23, 2017

An FDA inspection of Elite One Source Nutritional Services (EOS-L) in Lolo, MT, also known as Nutritional Laboratories International, Inc. (NLI), was conducted on August 23, 2017. This facility functions as a dietary supplement and drug packer, storage, and distribution site, and is a component of the Elite One Source Nutritional Services (EOS-M) manufacturing operation located in Missoula. The inspection was part of the Seattle District's FY17 work plan and followed regulatory guidelines outlined in CP 7321.008A for Dietary Supplements. The primary focus of this visit was to assess compliance with Good Manufacturing Practices (GMPs) concerning the packaging, labeling, storage, and distribution of finished dietary supplement products. The investigator observed activities such as the bottling of specific tablet products. Notably, the inspection concluded without any significant findings. No objectionable conditions or issues were identified related to the dietary supplement operations. Consequently, Form FDA-483, which documents inspectional observations, was not issued to the firm. This indicates that no immediate regulatory actions were required from the company. A previous inspection in December 2013 also resulted in no action, though concerns about warehouse temperature monitoring for drug products were discussed at that time. The current inspection classified the firm as "No Action Indicated."