Warning Letter: Improper maintenance of electronic records (m2819n)

Tags:

Ofni Systems
 
"Failure to
maintain laboratory records
to include complete data derived from all tests necessary to
assure compliance with established specifications
and standards [2 1 CFR 211. 194]. Specifically, your firm failed to properly maintain electronic files containing data secured in the course of tests from 20 HPLCS and 3 GLCS. Additionally, no investigation was conducted by your company to determine the cause of missing data and no corrective measures were implemented to prevent the recurrence of this event."

View the original warning letter.


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