Medical device maker Misonix Inc. said Wednesday it self disclosed possible FCPA violations to the DOJ and SEC.
Misonix said business practices by an independent Chinese entity that distributes its products in China “raise questions under the Foreign Corrupt Practices Act.”
Farmingdale, New York-based Misonix said it contacted the SEC on September 27 and the DOJ on September 28.
The company said it “may have had knowledge” of the China distributor’s business practices.
Misonix said it hired outside counsel to conduct an investigation that’s ongoing.
The company specializes in making ultrasonic surgical devices. It operates in over 45 countries. Revenues last year were about $22 million.
Misonix Inc. trades on Nasdaq under the symbol MSON.
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The FCPA disclosure in the Form 8-K (pdf) filed by Misonix Inc. on September 28, 2016 said:
On September 27, 2016 and September 28, 2016, respectively, Misonix, Inc. (the “Company”) contacted the Securities and Exchange Commission (“SEC”) and the U.S. Department of Justice (“DOJ”) to voluntarily inform both agencies that the Company may have had knowledge of certain business practices of the independent Chinese entity that distributes its products in China, which practices raise questions under the Foreign Corrupt Practices Act (“FCPA”).
The Audit Committee of the Board of Directors of the Company engaged outside counsel to conduct an internal investigation to review these and other matters. The internal investigation is ongoing. The Company has no current information derived from the investigation to date or otherwise to suggest that its previously reported financial statements and results are incorrect in any material respect.
The Company intends to cooperate fully with the DOJ and SEC as the investigation continues. At this stage, the Company is unable to predict what, if any, action the DOJ or the SEC may take or what, if any, penalties or remedial measures these agencies may seek. Any determination that the Company’s operations or activities are not in compliance with existing laws or regulations could result in the imposition of fines, civil and criminal penalties, equitable remedies, including profit disgorgement, and injunctive relief.
Richard L. Cassin is the publisher and editor of the FCPA Blog.