What happened
Original notice title
Celletech, Ltd MARCS-CMS 525396, August 28, 2018
From the archived source record
Based on our review of your product labeling, including product labeling on your website which was most recently accessed in August 2018, as well as product labels collected during an inspection from January 31 through February 2, 2017, of your facility located at 518 Tasman Street, Suite E, Madison, Wisconsin, we identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable U.S. Unapproved new human drugs FDA reviewed your website at the Internet address [see original source] in November 2017 and has determined that you take orders there for the products Easy Breath and Winter Tonic Plus. The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. In your response, identify the procedures you have taken or will take to completely correct the current violations and prevent similar ones. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
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
- dc1cf728cf23
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 →