Warning Letter: Compliance training (ucm2275453)

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Ofni Systems

“Your firm also failed to establish SOPs to ensure the following: (1) that all ADE information obtained from all sources are promptly conveyed to appropriate Jazz personnel and reviewed, in particular information obtained by your contracted central pharmacy and call center; (2) that all ADEs are evaluated against the U.S. package insert for seriousness and expectedness; (3) that all ADEs are reported accurately from source documentation to the FDA Form 3500A; and (4) that all ADEs that are the subject of 15-day Alert reports are promptly investigated and that all attempts to obtain additional information about the adverse experiences are recorded (as required by 21 CFR 314.80(c)(1)(ii)).

View the original warning letter.


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