<SEC-DOCUMENT>0001161697-16-000750.txt : 20160318
<SEC-HEADER>0001161697-16-000750.hdr.sgml : 20160318
<ACCEPTANCE-DATETIME>20160318171051
ACCESSION NUMBER:		0001161697-16-000750
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20160229
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20160318
DATE AS OF CHANGE:		20160318

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			REPRO MED SYSTEMS INC
		CENTRAL INDEX KEY:			0000704440
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				133044880
		STATE OF INCORPORATION:			NY
		FISCAL YEAR END:			0228

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-12305
		FILM NUMBER:		161516863

	BUSINESS ADDRESS:	
		STREET 1:		24 CARPENTER RD
		CITY:			CHESTER
		STATE:			NY
		ZIP:			10918
		BUSINESS PHONE:		845-469-2042

	MAIL ADDRESS:	
		STREET 1:		24 CARPENTER RD
		CITY:			CHESTER
		STATE:			NY
		ZIP:			10918
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>form_8-k.htm
<DESCRIPTION>FORM 8-K FOR 02-29-2016
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<P style="margin:0" align=center><B>UNITED STATES</B></P>
<P style="margin:0" align=center><B>SECURITIES AND EXCHANGE COMMISSION</B></P>
<P style="margin:0" align=center><B>Washington, DC 20549</B></P>
<P style="margin:0" align=center>&nbsp;</P>
<P style="margin:0; font-size:12pt" align=center><B>FORM 8-K</B></P>
<P style="margin:0" align=center>&nbsp;</P>
<P style="margin:0; font-size:12pt" align=center><B>CURRENT REPORT</B></P>
<P style="margin:0; font-size:12pt" align=center><B>Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</B></P>
<P style="margin:0" align=center>&nbsp;</P>
<P style="margin:0" align=center>Date of Report (Date of earliest event reported)&nbsp;&nbsp;&nbsp;<B><U>February 29, 2016</U></B></P>
<P style="margin:0" align=center>&nbsp;</P>
<P style="margin:0; font-size:14pt" align=center><B><U>REPRO MED SYSTEMS, INC.</U></B></P>
<P style="margin:0" align=center>(Exact name of registrant as specified in its charter)</P>
<P style="margin:0" align=center>&nbsp;</P>
<TABLE style="margin-top:0; font-size:10pt" cellpadding=0 cellspacing=0 align=center>
<TR><TD style="margin-top:0" valign=top width=240><P style="margin:0" align=center><B><U>New York</U></B></P>
</TD><TD style="margin-top:0" valign=top width=240><P style="margin:0" align=center><B><U>0-12305</U></B></P>
</TD><TD style="margin-top:0" valign=top width=240><P style="margin:0" align=center><B><U>13-3044880</U></B></P>
</TD></TR>
<TR><TD style="margin-top:0" valign=top width=240><P style="margin:0" align=center>(State or other jurisdiction<BR>
of incorporation)</P>
</TD><TD style="margin-top:0" valign=top width=240><P style="margin:0" align=center>(Commission<BR>
File Number)</P>
</TD><TD style="margin-top:0" valign=top width=240><P style="margin:0" align=center>(IRS Employer<BR>
Identification No.)</P>
</TD></TR>
</TABLE>
<P style="margin:0" align=center><BR></P>
<TABLE style="margin-top:0; font-size:10pt" cellpadding=0 cellspacing=0 align=center>
<TR><TD style="margin-top:0" valign=top width=288><P style="margin:0" align=center><B><U>24 Carpenter Road, Chester, New York</U></B></P>
</TD><TD style="margin-top:0" valign=top width=96><P style="margin:0" align=center><B><U>10918</U></B></P>
</TD></TR>
<TR><TD style="margin-top:0" valign=top width=288><P style="margin:0" align=center>(Address of principal executive offices)</P>
</TD><TD style="margin-top:0" valign=top width=96><P style="margin:0" align=center>(Zip Code)</P>
</TD></TR>
</TABLE>
<P style="margin:0" align=center><BR></P>
<P style="margin:0" align=center>Registrant&rsquo;s telephone number, including area code&nbsp;&nbsp;&nbsp;<B><U>(845) 469-2042</U></B></P>
<P style="margin:0" align=center>&nbsp;</P>
<P style="margin:0" align=center><U>not applicable</U></P>
<P style="margin:0" align=center>(Former name or former address, if changed since last report)</P>
<P style="margin:0" align=center>&nbsp;</P>
<P style="margin:0; text-align: justify">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):</P>
<P style="margin:0; text-align: justify">&nbsp;</P>
<P style="margin:0; text-align: justify">[ &nbsp;] &nbsp;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</P>
<P style="margin:0; text-align: justify">&nbsp;</P>
<P style="margin:0; text-align: justify">[ &nbsp;] &nbsp;Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</P>
<P style="margin:0; text-align: justify">&nbsp;</P>
<P style="margin:0; text-align: justify">[ &nbsp;] &nbsp;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</P>
<P style="margin:0; text-align: justify">&nbsp;</P>
<P style="margin:0; text-align: justify">[ &nbsp;] &nbsp;Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</P>
<P style="margin:0"><BR></P>
<HR noshade align="center" width="100%" size="2"><p style='page-break-before:always'></p><PAGE><BR>


<P style="margin:0"><B>ITEM 8.01 OTHER EVENTS.</B></P>
<P style="margin:0"><BR></P>
<P style="margin:0; text-indent:0; text-align: justify"><B>FDA Correspondence</B></P>
<P style="margin:0"><BR></P>
<P style="margin:0; text-indent:0; text-align: justify">On February 29, 2016, the Company received a Warning Letter (WL NYK-2016-26) from the New York District Office of US Food and Drug Administration (&ldquo;FDA&rdquo;) (&ldquo;the Letter&rdquo;) pursuant to observations arising from an FDA site inspection of the Company&rsquo;s manufacturing facility which occurred over a three week period in June 2015.</P>
<P style="margin:0"><BR></P>
<P style="margin:0; text-indent:0; text-align: justify">The Letter identified a variety of concerns and called for a detailed response to be submitted to the FDA by March 21, 2016. The Company contacted the FDA to clarify the issues raised in the Letter and is currently addressing the issues and providing additional documentation as needed. On March 18, 2016, the Company filed a response in great detail to the Letter. The Company must now await a determination from the FDA as to their satisfaction that our response sufficiently addressed the issues therein.  Because of the many proprietary details required to completely respond to the FDA, we will not publish the response letter.</P>
<P style="margin:0"><BR></P>
<P style="margin:0; text-indent:0; text-align: justify">There were no safety concerns raised by the points made in the warning letter and there was no requirement to withdraw any products from the market.</P>
<P style="margin:0"><BR></P>
<P style="margin:0"><BR></P>
<P style="margin:0" align=center><B>SIGNATURES</B></P>
<P style="margin:0; text-indent:48; text-align: justify">&nbsp;</P>
<P style="margin:0; text-indent:48; text-align: justify">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</P>
<P style="margin:0; text-indent:48">&nbsp;</P>
<TABLE style="margin-top:0; font-size:10pt" cellpadding=0 cellspacing=0 width=100%>
<TR><TD style="margin-top:0" valign=top><P style="margin:0">&nbsp;</P>
</TD><TD style="margin-top:0" valign=top width=360 colspan=2><P style="margin:0">REPRO MED SYSTEMS, INC.<BR>
(Registrant)</P>
</TD></TR>
<TR><TD style="margin-top:0" valign=top><P style="margin:0">&nbsp;</P>
</TD><TD style="margin-top:0" valign=top width=24><P style="margin:0">&nbsp;</P>
</TD><TD style="margin-top:0" valign=top width=336><P style="margin:0">&nbsp;</P>
</TD></TR>
<TR><TD style="margin-top:0" valign=top><P style="margin:0">Date: &nbsp;<U>March 18, 2016</U></P>
</TD><TD style="margin-top:0" valign=top width=24><P style="margin:0">By:</P>
</TD><TD style="margin-top:0" valign=top width=336><P style="margin:0"><U>/s/ Andrew I. Sealfon</U></P>
</TD></TR>
<TR><TD style="margin-top:0" valign=top colspan=2><P style="margin:0">&nbsp;</P>
</TD><TD style="margin-top:0" valign=top width=336><P style="margin:0">Andrew I. Sealfon<BR>
President and Chief Executive Officer</P>
</TD></TR>
</TABLE>
<P style="margin:0"><BR></P>
<P style="margin:0" align=center>- 2 -</P>
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