What happened
Original notice title
RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. MARCS-CMS 616560, September 30, 2021
From the archived source record
Department of Health and Human Services; and the former Commissioner of Food and Drugs Stephen Hahn, M.D., regarding the use of its “non-pharmaceutical products” (b)(4) . Without this information, we are unable to determine whether RAAS’s stated intent to comply with IND regulations is adequate to prevent similar violations in the future. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to adequately address this matter may lead to regulatory action. If you have any questions, please call Miah Jung, Pharm.D., M.S., at 240-402-3728. Your written response and any pertinent documentation should be addressed to: Miah Jung, Pharm.D., M.S.
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
- 9ae9cce17d87
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 →