FDANews
The QMN Weekly Bulletin

Eisai 483 Handed Form 483 after Investigators Cite Control Records, CAPA Procedures

Feb. 17, 2017

The FDA has served drug manufacturer Eisai Inc. with a Form 483 after an investigation revealed laboratory control issues and incomplete records.

Five observations were cited in the Form 483, including that the firm failed to initiate CAPA procedures and follow established test procedures as well as laboratory control mechanisms. The company also neglected to address the reoccurrence of test failures.

Others deviations from the established test methods were observed. Specifically, the analyst not only missed a required step during testing of a drug product, but also performed an extra step by removing excess water from the filter.

FDA investigators noted that the quality control managers have full access to chromatography data systems giving them the ability to alter and delete data as well as modifying system settings. Additionally, the password to unlock sensitive spreadsheets was shared among analysts within the quality control laboratory.

Inspectors also cited the firm as they witnessed a trained analyst frequently repeating the in-vitro dissolution tests for training purposes, but did not document the training properly in logbooks.

Remember, you have only 15 days to respond to a 483. Most of that time will go toward bringing your CAPA program into compliance. Don't waste a second trying to figure out how to communicate those plans in a way that will convince the FDA you are focused on improvement and committed to quality. Learn from those who have been there. Order your copy of Effective 483 Responses: Focus on CAPA Violations today.

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