Nutritional Laboratories International Inc – FDA EIR, Feb 7, 2019

This FDA Establishment Inspection Report documents a comprehensive, routine surveillance Current Good Manufacturing Practices (cGMP) inspection of Elite One Source Nutritional Services' Lolo, MT facility. The inspection, conducted from February 5-7, 2019, covered the company's operations as an Over-the-Counter (OTC) drug and dietary supplement repackager and relabeler. Specifically, the scope focused on the packaging and warehousing of OTC homeopathic oral solid dose drug products. The regulatory framework guiding this inspection was CPGM 7356.002, pertaining to Drug Repackers and Relabelers. The inspection meticulously assessed the facility's Quality, Facilities/Equipment, Materials, and Packaging/Labeling Systems. A significant finding of this review was the absence of any major violations or issues. Consequently, the FDA did not issue a Form 483, Inspectional Observations, which indicates compliance with regulatory requirements. This positive outcome signifies that Elite One Source Nutritional Services' Lolo facility demonstrated adherence to cGMP standards during the inspection period. As no deficiencies were identified, no specific required corrective actions were mandated by the FDA, reflecting sound operational practices at the site.