FDAnews Device Daily Bulletin

Orthopedic Surgical Devicemaker Gets GMP Warning Letter

Oct. 27, 2009
Frontier Devices’ Pelham, Ala., facility failed to document disposition of nonconforming product, according to an Aug. 27 warning letter posted recently to the FDA’s website. A number of distraction drivers manufactured at the plant in March 2008 were documented as having nonconforming specifications, the letter says. Frontier told the FDA investigator that the drivers were prototypes and the lot was released for distribution. The company did not maintain documentation of the review, disposition or justification for use of the nonconforming product, according to the letter.
The GMP Letter