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 on Friday.
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.