What happened
Original notice title
Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc. MARCS-CMS 620224, August 05, 2022
From the archived source record
Based on the inspectional findings and subsequent review of your product labels and labeling, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. We received your correspondence sent electronically on October 13, 2021, November 11, 2021, and December 22, 2021, concerning our inspectional observations listed on the FDA-483, Inspectional Observations, issued to you at the close of the inspection. Adulterated Dietary Supplements The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. The significant violations of CGMP requirements observed during the inspection include, but are not limited to, the following: 1. You failed to verify, for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.75(c). Specifically, you have not provided adequate documentation of your basis for determining that compliance with the specification(s) selected under 21 CFR 111.75(c)(1), through the use of appropriate tests or examinations conducted under 21 CFR 111.75(c)(2), will ensure that your finished batch of dietary supplements meets all product specifications for identity, purity, strength, and composition, and the limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the dietary supplement, as required by 21 CFR 111.75(c)(3), for the
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 47c227d999f0
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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