Warning Letter: No validation protocol (g6139d)

Tags:

Ofni Systems
 
"Failure to use the design process for the design changes made to the Biad nuclear imaging system and failure to have written design change control procedures. [21 CFR 820.30(i)] Specifically, the design change (retrofit) your firm made to the Biad nuclear imaging system as a result of a complaint that the detector head on the Biad nuclear imaging system fell and trapped a patient (See item #1 above) was not performed using design controls. There is no formal approval of the change, no risk assessment was documented, and there is
no verification/ validation protocol
."

View the original warning letter.


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