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Repro-Med Systems, Inc. MARCS-CMS 478416 —

Repro-Med Systems, Inc.

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo


MDRHO, Division 1
One Montvale Ave
Stoneham, MA 02180 


November 20, 2017

Via email

Andrew I. Sealfon
President and CEO
Repro-Med Systems, Inc.
24 Carpenter Road
Chester, NY 10918

Dear Mr. Sealfon:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2016-26, dated February 26, 2016. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


William MacFarland
Acting Director Compliance Branch
Office of Medical Device and Radiological Health Operations Division 1/East 

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