Warning Letter — AseptiKits, LLC
The FDA issued a Warning Letter to AseptiKits, LLC on June 4, 2026, following an evaluation by the Center for Devices and Radiological Health (CDRH).
This notice affects AseptiKits, LLC, as well as regulatory and quality personnel involved in the manufacturing and distribution of medical device kits.
The issuance of a Warning Letter by CDRH signifies that prior responses to inspectional observations may have been deemed inadequate by the agency. This represents an escalation in enforcement that could lead to restricted product distribution or the withholding of future device approvals until the documented violations are remediated.
Review internal Quality Management System (QMS) protocols to ensure alignment with CDRH expectations. Conduct an immediate audit of any outstanding FDA inspection observations to ensure CAPA plans are sufficient to prevent escalation to a Warning Letter.
FDA Warning Letter issued to: AseptiKits, LLC. 06/04/2026 — Center for Devices and Radiological Health. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aseptikits-llc-728184-06042026
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