Home » Endotec Warned for Investigation, Design Validation Failures
Endotec Warned for Investigation, Design Validation Failures
Orthopedic devicemaker Endotec has been warned for several good manufacturing practice violations, including investigation failures for a device
part that fell out during surgery. Although Endotec determined the mating holes of a tibial platform’s pin stop were oversized, causing it to fall
out, the company did not find the root cause necessary to implement a corrective or preventive action, according to the Oct. 22 warning letter posted
to the FDA’s website last month. The pin stop malfunction has occurred previously, it adds.
The GMP Letter
The GMP Letter
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