Warning Letter: Failure to adequately validate software (ucm441879)

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Ofni Systems

“Failure to adequately validate software used as part of production and quality systems for its intended use according to an established protocol as required by 21 CFR 820.70(i). Specifically, you did not validate your CNC Lathe and MAS 90 software used in manufacturing and labeling, respectively.”

View the original warning letter.


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