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Cleveland Manufacturer Violated OFAC Sanctions By Allowing Shipments To Iran - Know Your Customer and Know Their Customer

Client Alert

Between 2013 and 2017, UniControl exported 21 shipments of its products to two European customers. These 21 shipments were subsequently reexported to Iran, which violated the Iranian Transactions and Sanctions Regulations (“ITSR”) listed in 31 CFR Part 560.

WARNING SIGNS

UniControl encountered multiple alerts before and during this period and failed to take proper actions. In 2010, several years prior to the first of these shipments, a European trade partner of UniControl inquired whether UniControl could supply a significant market it had identified in Iran. UniControl turned down the opportunity but did not confirm that the sales to this European partner were not then being shipped to the Iranian market.

In 2014, UniControl and a European customer entered a sales agreement that listed Iran as a country to which the partner could re-sell these products. In 2016, UniControl offered to ship products directly to a purported third-party European end user, but the customer refused this offer in an attempt to obfuscate the end user. At European trade conferences, UniControl had direct interactions with Iranian nationals, but did not question their European trade partner on the interest. Finally, UniControl received a request from its European partner to remove the “Made in USA” labels from its products with the explanation that the Iranian end user may have issues with the product origin.

FIXING THE PROBLEM

UniControl consulted with outside counsel and then voluntarily self-disclosed these violations. In total, UniControl engaged in 21 prohibited transactions with a total product value of $687,189. The maximum statutory penalty that UniControl faced was $5,423,766. However, once all mitigating and aggravating factors were weighed, UniControl was able to reach a settlement with OFAC for $216,464.

Parallel to UniControl’s cooperation with OFAC and ceasing all shipments to its European trade partners, the company also righted its own “compliance ship.” This began by retaining outside counsel to strengthen their export control procedures. End-user certificates were created to make sure that buyers are not reselling to prohibited end users. These certificates are also requested from second and third level buyers of reexported products. UniControl added a Destination Control Statement within the footer of many of their trade documents to remind recipients of the restrictions on reselling, transferring, manipulating, or otherwise disposing of their products.

For a review of your export policies and processes, or questions on trade compliance, please contact International Law Attorney Kevin Burwell at kdburwell@bmdllc.com or 330-253-3715. 


CMS Requires Providers to Use an Updated Advance Beneficiary Notice (ABN) Form by May 12, 2026

CMS has released an updated Advance Beneficiary Notice of Noncoverage (ABN), Form CMS-R-131, that all providers and suppliers must begin using by May 12, 2026. The revised form includes clearer language and formatting updates intended to improve patient understanding and compliance.

CMS and Ohio Ramp Up Fraud Enforcement in Home Health and Hospice

CMS and Ohio have launched sweeping new fraud prevention initiatives targeting home health and hospice providers, signaling a period of heightened scrutiny for enrollment, billing, documentation, and EVV compliance. While aimed at combating fraud, these measures also create significant operational and due process risks for compliant agencies, making proactive compliance programs, auditing, and governance more important than ever.

MYTH BUSTER: Can a New Chiropractor Bill Under An Established Chiropractor’s NPI?

Many chiropractic practices mistakenly believe a newly hired chiropractor can bill under an established chiropractor’s NPI while waiting for credentialing approval. In most cases, this is not permitted. Claims should be submitted under the NPI of the chiropractor who actually rendered the service to avoid compliance risks, including potential False Claims Act exposure. This article outlines key billing rules, common exceptions, and practical compliance tips for chiropractic practices.

RNs and APRNs Take Note: Ohio Board of Nursing Mandates a New CE Reporting Period

Ohio’s Board of Nursing has updated the continuing education reporting period for RNs and APRNs. Beginning March 26, 2026, CE credits must be completed between July 1 and June 30 of odd-numbered years, replacing the previous November to October timeframe.

Ohio Med Spas: Peptide Do's and Do Not's

Recent guidance from the Ohio Board of Pharmacy outlines key compliance requirements for med spas using peptides. While some peptide drugs are FDA approved, others are not or cannot be compounded. Med spa operators should ensure they source medications from licensed suppliers, avoid non-approved or “research use only” products, and follow all compounding and storage regulations to maintain compliance and avoid enforcement actions.