Warning Letter: Failure to prevent unauthorized access or prevent omission of data (ucm501282)

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Ofni Systems

Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data.

During the inspection, an FDA investigator discovered a lack of basic laboratory controls to prevent changes to your firm’s electronically stored data and paper records. 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.

…..Specifically, your Quality Control (QC) analysts used administrator privileges and passwords to manipulate your high performance liquid chromatography (HPLC) computer clock to alter the recorded chronology of laboratory testing events.

 

View the original warning letter.


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