What happened
Original notice title
NatureLab Corp. MARCS-CMS 625768, July 12, 2022
From the archived source record
During the inspection, we identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA regulations. We address your responses below, in relation to each of the noted violations. Adulterated Dietary Supplements The inspection revealed serious violations of the FDA’s regulations for 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 supplements 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. Limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required in 21 CFR 111.70(b)(3). b. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Documentation that the finished dietary supplement meets specifications for identity, purity, strength, composition, and limits on contamination and for packaging and labeling [21 CFR 111.260(i)]; i. The “ (b)(4) ,” “ (b)(4) ,” and “ (b)(4) ” products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. The product “ (b)(4) ” and “ (b)(4) ” products are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because each label fails to declare the correct number of servings per container in accordance with 21 CFR 101.36(b)(1)(ii).
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
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- 9751aa2f507a
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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