What happened
Original notice title
Golden Lab LLC MARCS-CMS 625783, May 26, 2022
From the archived source record
Based on our inspection and our review of labeling collected during the inspection, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). Unapproved New Drugs and Misbranded Drugs During the inspection, our investigators reviewed your product labels and your website at www.doctorsoptimalformula.com, from which website you take orders for your DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule, DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule. 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 DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule and DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule 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)]. Dietary Supplement cGMP Violations During the inspection, our investigators found significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements, Title 21 Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations render dietary supplements 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)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet cGMP regulations for dietary supplements.
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
- 61886ed2c52d
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.
Sources, dates, and coverage →