Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc.
FDA issued a warning letter to Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc. (Missoula, MT) following a September 2021 facility inspection. The agency found serious CGMP violations — including failures to verify finished batch specifications, follow quality control procedures, validate testing methodologies, and establish proper reference standard criteria — rendering multiple dietary supplement products adulterated. Additionally, several products were found misbranded due to incorrect serving size declarations, improper nutrient naming conventions, and failure to declare ingredients by their common or usual names. FDA required a written response within 15 working days and warned that failure to correct violations could result in seizure or injunction.
Flagged claims (3)
Adults should take 1 tablet twice daily. Children aged 7-16 years should take 1 tablet daily.
Percent daily values are based on a 2,000 calorie diet.
Take 1-2 chewable tablets daily as needed, at bedtime.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
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