2026-04-15 FDA Warning Letter: Unetixs Vascular, Inc. Cited for Premarket Approval/Adulterated
Letter issued · posted to fda.gov .
Subject as published: Premarket Approval/Adulterated
TL;DR
The short version: FDA issued a Warning Letter to Unetixs Vascular, Inc. on 2026-04-15 citing: Premarket Approval/Adulterated. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/unetixs-vascular-inc-724245-04152026
Argus analysis
Unetixs Vascular, Inc. (MARCS-CMS 724245) received an FDA Warning Letter dated April 15, 2026 from the Center for Devices and Radiological Health. The letter cites: Premarket Approval/Adulterated. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 5, 2026.
Device PMA/IDE letters cite 21 CFR Part 812 (investigational device exemptions) or Part 814 (premarket approval), alongside adulteration provisions in 21 USC 351. Common findings involve marketing or distributing a significant-risk device without an approved PMA or IDE, or failing to maintain the records an approved application requires.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same general compliance category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Unetixs Vascular, Inc. MARCS-CMS 724245 — April 15, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Mr. Neeraj Jha Recipient Title President/CEO Unetixs Vascular, Inc. 6901 TPC Drive, Suite 300 Orlando , FL 32822 United States (b)(4) Issuing Office: Center for Devices and Radiological Health United States WARNING LETTER CMS # 724245 April 15, 2026 Dear Neeraj Jha: During an inspection of your firm, Unetixs Vascular, Inc., located in Warwick, RI from September 19, 2025, through December 4, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures vascular diagnostic ultrasound systems, including the ROODRA and 2CP devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Our inspection revealed that the MultiLab Series ROODRA and 2CP vascular diagnostic devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device with its current modifications into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed. Specifically, the modified MultiLab Series ROODRA and 2CP vascular diagnostic devices that you are distributing do not have 510(k) clearance. While MultiLab Series ROODRA and 2CP vascular diagnostic devices have a prior 510(k) clearance (K904392), the modified devices include both design and labeling modifications – as documented in your firm’s “Regulatory Change Assessment - ENGINEERING CHANGE RECORD ECR # 0137 - Changing all applicable items from luer connections to bayonet connections” – which could significantly affect the safety and effectiveness of the device and, under 21 CFR …
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- What is the regulatory background for a Warning Letter warning letter?
- FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Unetixs Vascular, Inc. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Unetixs Vascular, Inc. as of 2026-05-05. Argus ingests new FDA enforcement records daily.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). 2026-04-15 FDA Warning Letter: Unetixs Vascular, Inc. Cited for Premarket Approval/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-unetixs-vascular-inc-2026-04-15-warning-letter
"2026-04-15 FDA Warning Letter: Unetixs Vascular, Inc. Cited for Premarket Approval/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-unetixs-vascular-inc-2026-04-15-warning-letter.
Argus HQ Research. "2026-04-15 FDA Warning Letter: Unetixs Vascular, Inc. Cited for Premarket Approval/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-unetixs-vascular-inc-2026-04-15-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_unetixs_vascular_inc_2026_04_15_warning_letter_2026,
title = {2026-04-15 FDA Warning Letter: Unetixs Vascular, Inc. Cited for Premarket Approval/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-unetixs-vascular-inc-2026-04-15-warning-letter},
note = {Accessed: July 13, 2026}
}