Warning Letter: Failure to validate(g4689d)

Tags:

Ofni Systems
 
"Your firm failed to
validate and approve processes
whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75(a). Your firm failed to validate the following operations c) Validation of Borland Compiler is incomplete because
software used to control passwords
was not addressed (FDA 483, Item #3)."

View the original warning letter.


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