FDAnews Device Daily Bulletin

Risk Management Violations Lead to FDA Warning Letter

July 17, 2009
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Blackstone Medical did not adhere to its own risk management procedures after making design changes to its device, according to an FDA warning letter. The company took no actions to reduce the risk or create additional control measures after the risk priority numbers for the changed design fell within an unacceptable zone for set screws, multiaxial body assemblies, off-set body assemblies and multiaxial screws, the letter says.
The GMP Letter