Warning letterPosted June 30, 2026
FDA warning letter to AseptiKits, LLC
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
FDA posted a warning letter to AseptiKits, LLC on June 30, 2026; the letter is dated June 4, 2026. Subject: Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- AseptiKits, LLC
- Subject
- Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2026-06-04
- Posted by FDA
- 2026-06-30
- Source
- FDA warning letters ↗
CFR cited
The record cites 1 section of 21 CFR Part 880.
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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