Warning Letter Roundup – January 2017
By Deb Bartel,
This post was recently updated on August 4, 2020
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.
Our consultants have extensive pharmaceutical, biotech, and medical device industry experience. If you are facing an FDA inspection, EMA inspection, or customer audit, it’s not too late to get help.
Talk to our CSV experts today about how they can help you meet FDA and international regulatory expectations.
To download other FDA Warning Letters and 483s, visit our document Library.
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