Warning letterPosted October 27, 2026
FDA warning letter to Peter Schiff Enterprises
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
FDA posted a warning letter to Peter Schiff Enterprises on October 27, 2026; the letter is dated August 26, 2026. Subject: Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- Peter Schiff Enterprises
- Subject
- Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2026-08-26
- Posted by FDA
- 2026-10-27
- Source
- FDA warning letters ↗
CFR cited
The record cites 18 sections of 21 CFR Parts 801, 803, 807, 820, 830 and 890.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
More
Watch Peter Schiff Enterprises
A free account shows the last 7 days of every record. Pro adds a watchlist: one email when FDA acts on a company you name.
From FDA warning letters. The record may have changed since it was read.
Approve Suite is not affiliated with FDA, or with Peter Schiff Enterprises.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.