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Home » Devicemaker Surprised by Warning Letters, Had Responded to 483
Devicemaker Surprised by Warning Letters, Had Responded to 483
March 1, 2013
Bacterin officials are wondering whether the FDA did not review a second response to a set of Form 483s before slapping the devicemaker with two warning letters, a company spokesman said. The letters came just ahead of an unrelated federal subpoena dealing with physician compensation. The warning letters — dated Jan. 28 and posted to the agency’s website Feb. 12 — concern manufacturing problems at Bacterin’s Belgrade, Mont., plant identified during two overlapping inspections last July.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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