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Orthopedic Device Maker Gets Warning Letter

FDA cites firm for not following Good Manufacturing Practice requirements.

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By: Michael Barbella

Managing Editor

An inspection of a Frontier Devices Inc. facility in Pelham, Ala., has found that the firm is a manufacturer of dental implants and orthopedic surgical instruments for the spine, and that the company does not follow Current Good Manufacturing Practice requirements, according to the U.S. Food and Drug Administration.

Don Petersen, Ph.D., director of quality assurance and regulatory affairs, responded to the warning letter.

For the complete warning letter and response, click here.

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