Warning Letter: Failure to have computerized systems with sufficient controls (ucm484910)

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Ofni Systems

” Failure to have computerized systems with sufficient controls to prevent unauthorized access or changes to data.

During the inspection, FDA investigators discovered a lack of basic laboratory controls to prevent changes to your firm’s electronically stored data. Your firm relied on incomplete records to evaluate the quality of your drugs and to determine whether your drugs conformed with established specifications and standards.

View the originalwarning letter.


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