Cadila Healthcare Limited

Cadila Healthcare Limited.
Product: pharmaceutical manufacturing facilities
Date: 12/23/2015

Our investigators observed specific violations during the inspection, including, but not limited to the following.
Your firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data.

a. Your firm failed to adequately control the use of computerized systems in the quality control laboratory. Our inspection team found that the laboratory manager had the ability to delete data from the Karl Fischer Tiamo software. During our limited review of your Karl Fischer data, we found that one file had been deleted. However, because the audit trail function for the Karl Fischer Tiamo software was not activated, and because eight different analysts share a single username and password, you were unable to demonstrate who performed each operation on this instrument system. You do not have a record of the acquisition of all data, nor do you have records of changes to or modifications of such data.

FDA District Office: CDRH

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