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Anonymous
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Why are we doing business with companies/countries that we have to get formal permission for to do an "inspection" of...I'm sure the conditions on the day of the inspection are the same as they were months earlier when we requested permission :roll: :???:
How many folks is GW going to kill or maim in the name of Freetrade? :???:
And this is what occurs when we ship all our production overseas and allow our needs to be filled by one company/country....
How many folks is GW going to kill or maim in the name of Freetrade? :???:
February 14, 2008, 8:11 am
China Plant Produced Key Ingredient for Baxter’s Heparin
Posted by Joe Mantone
A new twist was added to an investigation into deadly allergic reactions to a generic blood thinner from Baxter International.
The FDA hadn’t inspected a Chinese facility responsible for the active ingredient in the drug, heparin, that is derived from pig intestines, the WSJ reports on page one.
It’s not known whether the facility played a role in the drug’s problems; Baxter had previously announced it was halting production of the drug, given to patient undergoing dialysis and some surgeries, because of bad reactions and fatalities.
“While no FDA inspection of the facility has been conducted to date, preparations are being made to perform an inspection as soon as possible,” an FDA spokeswoman said in an emailed statement. “We have already requested expedited access to the facility, facilitated through a recently signed agreement with the Chinese State Food and Drug Administration.”
Whether the facility played a role in the problems of heparin or not, the revelation is likely to bring fresh criticism to the FDA’s policy of inspecting foreign plants.
The GAO has said that the FDA may only inspect around 7% of foreign drug-making facilities in a year and some see it as a warning sign to increase funding for the taxed agency. China’s State Food and Drug Administration has also been trying to crack down on unregulated chemicals getting into drugs.
And this is what occurs when we ship all our production overseas and allow our needs to be filled by one company/country....
The company provides roughly 50 per cent of all the heparin administered in the US, and it is thought that further recalls could create a shortage in the drug that could be more dangerous to patients that the increased risk of adverse reactions.