What happened
Original notice title
West Coast Laboratories, Inc. MARCS-CMS 672954, June 12, 2024
From the archived source record
Based on the inspectional findings we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Adulterated Dietary Supplements The inspection of your facility from October 3, 2023, through October 24, 2023, identified serious violations of 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 the Calcium Pyruvate, Chromium Picolinate, and CalComplex products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Your significant violations of the CGMP requirements are as follows: 1. Misbranded Dietary Supplements In addition, we reviewed product labels collected during the inspection and have determined the Calcium Pyruvate, Chromium Picolinate, and Calcium Complex Formula #3 (CalComplex) products you manufacture are misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with the labeling requirements for dietary supplements. The Calcium Pyruvate and Chromium Picolinate products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1] may receive a report of a serious adverse event with such dietary supplement. 2. The CalComplex, Calcium Pyruvate, and Chromium Picolinate products are misbranded within the meaning of section 403 (q)(5)(F) of the Act (21 U.S.C. 343(q)(5)(F)) in that the presentation of the nutrition information on the labeling of these products does not comply with 21 CFR 101.36 and 101.9.
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
- 3c22046429e9
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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