<SEC-DOCUMENT>0000200406-11-000038.txt : 20110310
<SEC-HEADER>0000200406-11-000038.hdr.sgml : 20110310
<ACCEPTANCE-DATETIME>20110310163801
ACCESSION NUMBER:		0000200406-11-000038
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20110310
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110310
DATE AS OF CHANGE:		20110310

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			JOHNSON & JOHNSON
		CENTRAL INDEX KEY:			0000200406
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				221024240
		STATE OF INCORPORATION:			NJ
		FISCAL YEAR END:			0209

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-03215
		FILM NUMBER:		11678930

	BUSINESS ADDRESS:	
		STREET 1:		ONE JOHNSON & JOHNSON PLZ
		CITY:			NEW BRUNSWICK
		STATE:			NJ
		ZIP:			08933
		BUSINESS PHONE:		732-524-2455

	MAIL ADDRESS:	
		STREET 1:		ONE JOHNSON & JOHNSON PLZ
		CITY:			NEW BRUNSWICK
		STATE:			NJ
		ZIP:			08933
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
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<DESCRIPTION>MCNEIL-PPC, INC. CONSENT DECREE 8-K
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Date of report (Date of earliest event reported):&#160;&#160;March 10, 2011</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 36pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">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:</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Item 8.01&#160;&#160;Other Events.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font id="TAB1" style="MARGIN-LEFT: 36pt"></font>On March 10, 2011, McNEIL-PPC, Inc., a subsidiary of the Registrant, announced today that it has finalized the terms of a Consent Decree of Permanent Injunction (Consent Decree) with the U.S. Food and Drug Administration for manufacturing facilities operated by the McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. in Las Piedras, PR, Fort Washington, PA, and Lancaster, PA.&#160;&#160;The Consent Decree is subject to approval by the United States District Court for the Eastern District of Pennsylvania.&#160;&#160;The related press release dated March 10, 2011 is attached as Exhibit 99.1 to this Report.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">99.1&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;McNEIL-PPC, Inc. press release dated March 10, 2011</font></div>

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<TYPE>EX-99.1
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<DESCRIPTION>MCNEIL-PPC, INC. PRESS RELEASE EXHIBIT 99.1
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 36pt; MARGIN-RIGHT: -36pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; TEXT-DECORATION: underline">Exhibit 99.1</font></font></div>

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<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;<font style="DISPLAY: inline; FONT-WEIGHT: bold">MEDIA INQUIRIES:<font id="TAB2" style="LETTER-SPACING: 9pt">&#160;</font></font></font></td>
<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;<font style="DISPLAY: inline; FONT-WEIGHT: bold">INVESTOR RELATIONS:</font></font></td>
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<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;Bonnie Jacobs<font id="TAB2" style="LETTER-SPACING: 9pt">&#160;</font></font></td>
<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;Louise Mehrotra</font></td>
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<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;215-273-8994 (office)</font></td>
<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;732-524-6491</font></td>
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<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;856-912-9965 (mobile)</font></td>
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<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">Tina Pinto</font></td>
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<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;Marc Boston<font id="TAB2" style="LETTER-SPACING: 9pt">&#160;</font></font></td>
<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">732-524-2034</font></td>
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<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;215-273-7649 (office)</font></td>
<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;</font></td>
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<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;215-429-7034 (mobile)</font></td>
<td width="50%"><font style="FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;</font></td>
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: -18pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">MCNEIL-PPC, INC. ANNOUNCES SIGNING OF CONSENT DECREE COVERING </font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: -18pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">MANUFACTURING FACILITIES IN LAS PIEDRAS, PR, FORT WASHINGTON, PA, AND LANCASTER, PA</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: -18pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">FOR IMMEDIATE RELEASE &#8211; Fort Washington, PA (March 10, 2011) &#8211; McNEIL-PPC, Inc. announced today that the company has finalized the terms of a Consent Decree of Permanent Injunction (Consent Decree) with the U.S. Food and Drug Administration (FDA) for manufacturing facilities operated by the McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. in Las Piedras, PR, Fort Washington, PA, and Lancaster, PA. The Consent Decree is subject to approval by the United States District Court for the Eastern District of Pennsylvania.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: -18pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In July 2010, McNeil submitted to the FDA and has been diligently implementing a Comprehensive Action Plan (CAP) to improve quality systems at its U.S. manufacturing facilities. McNeil believes that the terms of the Consent Decree recognize the progress made in remediation efforts to date, and are consistent with the commitments the company has made as part of the CAP. The Consent Decree allows McNeil to continue the work already initiated under the CAP, and identifies procedures that will help provide additional assurance of product quality to the FDA.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: -18pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-SIZE: 10pt">Under the terms of the Consent Decree, the company will continue to operate the manufacturing facilities in Las Piedras, PR and Lancaster, PA. The company will work with an independent expert who will inspect these sites and issue recommendations. Based on these findings, the company will develop remediation plans to address observations identified by the independent expert. These plans will be submitted to the FDA and are subject to the agency&#8217;s approval. In addition, the company and the FDA have agreed on a plan to have the independent expert review certain manufacturing records at the two sites while remediation is ongoing to ensure that products released from the sites continue to meet quality standards. The company expects that the Consent Decree will govern the company&#8217;s operation of the facilities for a period of at least five years following the completion of the remediation plan.</font></font></div>

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<div style="DISPLAY: block; TEXT-INDENT: 0pt"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In April 2010, the company voluntarily closed its manufacturing facility in Fort Washington, PA and announced that it would not re-open the plant until it completed its planned remediation efforts at that facility. According to the terms of the Consent Decree, the company will not re-open the Fort Washington facility unless it first has completed remediation efforts at the facility, receives a certification of compliance from an independent expert, and then receives approval from the FDA.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: -18pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">McNEIL-PPC, Inc. is a subsidiary of Johnson &amp; Johnson.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: -18pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995.&#160; These statements are based on current expectations of future events.&#160; If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from McNeil-PPC, Inc. or Johnson &amp; Johnson's expectations and projections.&#160; Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment.&#160; A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson &amp; Johnson&#8217;s Annual Report on Form 10-K for the fiscal year ended January 2, 2011.&#160; Copies of this Form 10-K, as well as subsequent filings, are available online at <font style="DISPLAY: inline; TEXT-DECORATION: underline">www.sec.gov</font>, <font style="DISPLAY: inline; TEXT-DECORATION: underline">www.jnj.com</font> or on request from Johnson &amp; Johnson.&#160; Neither McNeil-PPC, Inc. nor Johnson &amp; Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.)</font></div>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
