Warning letterPosted September 23, 2025
FDA warning letter to The Richline Group, Inc.
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
FDA posted a warning letter to The Richline Group, Inc. on September 23, 2025; the letter is dated August 25, 2025. Subject: Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- The Richline Group, Inc.
- Subject
- Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2025-08-25
- Posted by FDA
- 2025-09-23
- Source
- FDA warning letters ↗
CFR cited
The record cites 12 sections of 21 CFR Parts 801, 803, 807, 820 and 830.
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.
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