Warning Letter Roundup – December 2016
By Deb Bartel,
This post was recently updated on July 6, 2020
The FDA sends Warning Letters and 483s to companies that 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:
F.P. Rubinstein Y Cia
This Warning Letter contains many observations impacting software quality, including failures in validation, software safety, and qualification of software consultants and contractors. Download this warning letter.
Interpharm Praha
This Warning Letter contains multiple observations regarding the integrity of laboratory system data, including the deletion of at least 1,441 test results.
Tosoh Bioscience
This Warning Letter cites the failure to investigate the installation of the wrong version of software in a medical product. Download this warning letter.
Teva Pharmaceutical Works
This Warning Letter contains citations for failure to prevent deletion of laboratory system records and failure to review system audit trails. 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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