Warning letterPosted July 7, 2026
FDA warning letter to BlephEx, LLC
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
FDA posted a warning letter to BlephEx, LLC on July 7, 2026; the letter is dated June 3, 2026. Subject: Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- BlephEx, LLC
- Subject
- Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2026-06-03
- Posted by FDA
- 2026-07-07
- Source
- FDA warning letters ↗
CFR cited
The record cites 17 sections of 21 CFR Parts 801, 803, 806, 807, 820, 830, 878 and 886.
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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