Warning Letter: Failure to provide adequate controls for audit trail, backup, common log-in and password, validation, procedures, and training (ucm448433)

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Ofni Systems

“Failure to prevent unauthorized access or changes to data and to provide adequate controls preventing data omissions.

Our inspection noted that your firm did not retain complete raw data from testing performed to assure the quality of
[redacted], API. Specifically, our inspection revealed your firm did not properly maintain a back-up of HPLC chromatograms that form the basis of your product release decisions. Our inspection revealed discrepancies between the printed chromatograms and the operational qualification protocol for the High Performance Liquid Chromatography (HPLC) system, which is intended to demonstrate correct operation of the HPLC. These discrepancies included injection sequences and values to calculate relative standard deviation (RSD).

While investigating these discrepancies, our investigator requested the original electronic raw data. Your quality unit, after consulting with the Information Technology (IT) department, stated they were unable to retrieve the original electronic raw data because back-up discs were unreadable. Your quality unit then stated that back-up disks have been unreadable since at least 2013. Your HPLC system is used to test
[redacted], API for batch release. However, without complete, accurate, reliable, or retrievable raw data about the HPLC system’s qualification, you lacked complete assurance that the system was operating as intended.

You also failed to have proper controls in place to prevent unauthorized manipulation of your laboratory’s raw electronic data. Our inspection revealed your HPLC system did not have access controls to prevent alteration or deletion of data. Your HPLC software lacked an audit trail recording any changes to the data, including: previous entries, who made changes, and when changes were made. During the inspection, we also noted that all laboratory employees shared a common log-in and password to access the system.

This lack of control over the integrity of your data raises questions about your analytical data’s authenticity and reliability, and about the quality of your APIs. We note that the September 2008 FDA inspection uncovered concerns over your handling of raw analytical data, including discrepancies between laboratory notebooks and printed chromatograms.”

View the original warning letter.


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