The FDA sends Warning Letters and 483s to companies who significantly violate FDA regulations. We gather those related to computer system issues so that you can help ensure your organization doesn’t fail an inspection for similar violations.
Organizations who received warning letters citing computer system issues:
Wockhardt
This Warning Letter cites the failure to validate 12 systems. Download this warning letter.
Zyno Medical
This Warning Letter notes issues with installation verification of documentation of the software version within a medical device. Download this warning letter.
Sekisui Medical
This Warning Letter cites the failure to retain records from laboratory systems and the failure to have accurate audit trails. Download this warning letter.
Srikem Laboratories
This Warning Letter contains observations for issues with the integrity of raw, electronic data files. Download this warning letter.
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To download other FDA Warning Letters and 483s, visit our document Library.