Warning Letter: No procedures on how to enter data in the electronic system (ucm444827)

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Ofni Systems

 
“Your procedure has not been updated to reflect the change that was made in 2011 to document all complaints on a form in your electronic system, and not on the hard copy “Product Inquiry/Complaint form” as required by section 6.3 of your complaint procedure. Additionally, there are no procedures on how to enter data in this electronic system.”

View the original warning letter.


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