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	<title>Comments on: FDA Chief Counsel Stymies Heparin Probe</title>
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	<description>News, Comment and Conversation</description>
	<pubDate>Mon, 07 Jul 2008 03:56:45 +0000</pubDate>
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		<title>By: James</title>
		<link>http://www.pharmalot.com/2008/04/fda-chief-counsel-stymies-heparin-probe/#comment-328286</link>
		<dc:creator>James</dc:creator>
		<pubDate>Thu, 01 May 2008 21:17:01 +0000</pubDate>
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		<description>I'm fascinated by the China manufacturing situation.

Pet food was contaminated with melamine.  Doesn't naturally occur in pet food, no reason for it to be in the same plant, and just happens to help cut costs and escapes inspector's notice.

Same is true for the contaminant found in the offending heparin.

Read an NYT article that indicates, amongst other issues, some Chinese dumpling manufacturers treat cardboard with chemicals to give it the appearance of meat or veg filling.

There seems to be a pattern and acceptance of fraudulently using dangerous fillers in place of food and drugs in China.  Combine this with lax FDA oversight, and nowhere near the resources to ensure sufficient compliance with GMPs, and we have a ticking time bomb.  

I wonder how many APIs have been replaced with useless, but not dangerous, ingredients, and how long it will be before those, if ever, are discovered.  As one of my friends from China stated, it is the "wild wild East."  

We are playing a game of Russian Roulette with a Chinese gun.  We are only now stationing FDA inspectors there on a permanent basis.  Unless and until we can assure GMP compliance (as long as that is the bar), we should have country of origin labeling.</description>
		<content:encoded><![CDATA[<p>I&#8217;m fascinated by the China manufacturing situation.</p>
<p>Pet food was contaminated with melamine.  Doesn&#8217;t naturally occur in pet food, no reason for it to be in the same plant, and just happens to help cut costs and escapes inspector&#8217;s notice.</p>
<p>Same is true for the contaminant found in the offending heparin.</p>
<p>Read an NYT article that indicates, amongst other issues, some Chinese dumpling manufacturers treat cardboard with chemicals to give it the appearance of meat or veg filling.</p>
<p>There seems to be a pattern and acceptance of fraudulently using dangerous fillers in place of food and drugs in China.  Combine this with lax FDA oversight, and nowhere near the resources to ensure sufficient compliance with GMPs, and we have a ticking time bomb.  </p>
<p>I wonder how many APIs have been replaced with useless, but not dangerous, ingredients, and how long it will be before those, if ever, are discovered.  As one of my friends from China stated, it is the &#8220;wild wild East.&#8221;  </p>
<p>We are playing a game of Russian Roulette with a Chinese gun.  We are only now stationing FDA inspectors there on a permanent basis.  Unless and until we can assure GMP compliance (as long as that is the bar), we should have country of origin labeling.</p>
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		<title>By: Jack2</title>
		<link>http://www.pharmalot.com/2008/04/fda-chief-counsel-stymies-heparin-probe/#comment-327303</link>
		<dc:creator>Jack2</dc:creator>
		<pubDate>Thu, 01 May 2008 15:59:47 +0000</pubDate>
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		<description>Was it "falling out of compliance" or was it intentional contamination?  A contaminant so devious, that it took the FDA and Baxter weeks to find AFTER they KNEW to look for a problem.</description>
		<content:encoded><![CDATA[<p>Was it &#8220;falling out of compliance&#8221; or was it intentional contamination?  A contaminant so devious, that it took the FDA and Baxter weeks to find AFTER they KNEW to look for a problem.</p>
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		<title>By: Lisa Van S</title>
		<link>http://www.pharmalot.com/2008/04/fda-chief-counsel-stymies-heparin-probe/#comment-325313</link>
		<dc:creator>Lisa Van S</dc:creator>
		<pubDate>Thu, 01 May 2008 01:43:15 +0000</pubDate>
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		<description>Daivid Nelson,.. Go Get'm... Kick Ass!!.....</description>
		<content:encoded><![CDATA[<p>Daivid Nelson,.. Go Get&#8217;m&#8230; Kick Ass!!&#8230;..</p>
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