What happened
Original notice title
Professional Botanicals, Inc. 7/6/17
From the archived source record
Based on the inspection, a review of the product labels collected during the inspection, and a review of your websites, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Because the observations on the Form FDA 483 and your responses relate to compliance with the cGMP regulations for dietary supplements, we discuss our assessment of your responses in the cGMP section of this letter (entitled “Adulterated Dietary Supplements”). Unapproved New Drugs Based on our recent review of your product labels and your website, www.professionalbotanicals.com, we have determined that the claims on your product labels and website establish that several of your firm’s products are drugs within the meaning of section 201(g)(1)(B) and/or (g)(1)(C) of the Act [21 USC § 321(g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are articles (other than food) intended to affect the structure or any function of the body. Adulterated Dietary Supplements Even if your product labels and websites did not contain claims that render the products unapproved new drugs, our investigator observed the following violations of FDA’s Current Good Manufacturing Practice (cGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which would render your products adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] for the reasons described below. The significant violations documented during the inspection include, but are not limited to, the following: 1. However, your response only provides specifications relating to temperature control and does not provide written procedures for operations such as control of storage location and conditions that will protect the dietary supplement under distribution from contamination or deterioration.
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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- ddb60204dbe7
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 →