Devicemaker Surprised by Warning Letters, Had Responded to 483

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