Warning Letter: Lack of validation (ucm292025)

Tags:

Ofni Systems
 
"There is no
established validation for the process
that uses Coordinate Measuring Machines (CMMs) to perform the only full-dimensional verification performed on the implant products fabricated in-house using Computer Numerical Control (CNC) machining equipment, for which there is also no
established validation process
. Your firm’s management confirmed that they do not conduct full verification of CMM measurements. Your firm’s response to this observation appears to be adequate. Your firm provided a
validation protocol
and reports for the measurement of ASDM products using the CMM. The results in these reports validate the repeatability and accuracy of the CMM in verifying
design specification
for all products fabricated in-house using the CNC machining equipment."

View the original warning letter.
 


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