What happened
Original notice title
Curtis Jacquot dba Pacific BioLogic Co. MARCS-CMS 664804, December 21, 2023
From the archived source record
The inspection revealed significant violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations Part 111 (21 CFR Part 111). In addition, FDA reviewed the labels for some of your products and the websites www.pacificbiologic.com and www.balanceandharmony.com in July 2023. Furthermore, several of your products are misbranded drugs under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] because they fail to bear adequate directions for their intended use(s). We acknowledge receipt of your response received via email dated July 14, 2023, which included your intended corrections to the observations of concern noted on the form FDA-483. Unapproved New Drugs We reviewed your websites www.pacificbiologic.com and www.balanceandharmony.com and we determined you take orders there for your products ArteClear Circulation 2, Headache Release, Natura-Mune – 2, Pain Release, and Attack 2. This is a repeat observation from the Warning Letter issued to you on April 17, 2014, and the items discussed with you in the Regulatory Meeting held on May 19, 2015. Misbranded Drugs A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your products listed above fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Adulterated Dietary Supplements Your dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements (21 CFR Part 111).
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
- 705b0620f74b
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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