Feb 1 CryoLife Inc said it received a
warning letter from U.S. health regulators after they determined
the company failed to adequately address earlier concerns over
the manufacturing of its medical devices and other products.
After a routine inspection of CryoLife's manufacturing
facilities, the U.S. Food and Drug Administration in October
issued a notice containing its observations on the preservation
and distribution of human tissue and the manufacturing of
medical devices at the company's plants.
Such notices typically contain observations of practices
that the FDA inspectors believe violate the agency's so-called
good manufacturing standards.
While CryoLife responded to the FDA notice by detailing
proposed corrective actions, the FDA did not find these
responses satisfactory, the company said in a regulatory filing
CryoLife, which makes surgical tools and devices, along with
preserving certain tissues that helps in cardiac and vascular
reconstruction, said it will work towards addressing the issues
the agency had highlighted in its warning letter.
The Kennesaw, Georgia-based company added it does not expect
the warning to have a material impact on its financial results.