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FDA seizure intended to drive "major changes" at Caraco
Continued violations of good manufacturing practices have led to the seizure of 33 medications and drug ingredients at plants in Michigan, the FDA says. U.S. Marshals last week visited generic drug maker Caraco Pharmaceutical facilities in Detroit, Farmington Hills and Wixom for the seizure, following a May 2009 inspection, October 31, 2008, FDA warning letter, and company-initiated recalls.
Oversized tablets, poor control of its raw materials, and a possible formulation error prompted the action. The May inspection yielded unresolved violations of cGMP requirements. "Today's seizure is intended to lead to major changes at Caraco's facilities," the FDA says in an announcement.
A Caraco announcement counters that the company believes corrective actions have been made and continual improvements are in process. "While we have not fully determined the impact of this action by the FDA on our financial condition, we believe that it may have a material adverse effect on our near term operations," the announcement says.
The company also says it anticipates working with the FDA to resolve concerns "as effectively and expeditiously as possible."
- read the FDA announcement
- here's an FDA Q&A with additional detail
- see the Caraco release
Related Articles:
FDA sidelines Caraco meds after quality issues
Caraco to add 600 jobs by 2012
Comments
Re: FDA:
This rogue agency, like it's corrupt and politicised counterpart the EPA, is waging war on American access to pharmaceuticals in advance of the communo-fascist attack on the broader health care system under the rubric of "Health Care Reform".
If there were any hope of reform through a thoroughly vicious and corrupt gangster government, with virtually all good men having been purged, marginalized or bought out over the last twenty years culminating in the monstrous regime we see today looting our society and selling out our country, then the answer to dealing with the FDA would be obvious: the agency would be immediately enjoined to cease all raids on pharmaceutical firms and immediately halt bans on all medications until independent review by outside medical experts take place on each and every medication in question with particular emphasis on the immediate effect on the long-term and critical user base of each population.The fascist-style raids in which the entire product output of pharmaceutical firms is halted and/or confiscated must be stopped immediately!
It goes without saying that extensive investigation of the political and financial connections of senior FDA officials ordering these attacks and outright product bans on long-proven pharmaceuticals be instituted immediately.
None of this is likely to happen,however, until members of the health-care and pharma industry find the courage of their forefathers and stand up like Americans and speak out loudly and forcefully against the tyranny and corruption emanating from this agency.
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