483
Erode Cancer CentreErode Cancer Centre – FDA 483, Nov 21, 2023
Record Details
The FDA inspected Erode Cancer Centre in Erode, India, a biopharmaceutics clinical facility, and issued a Form 483 with two observations. The inspection revealed significant deficiencies in the reporting of adverse events for enrolled subjects and the maintenance of complete case histories. These issues indicate a failure to adhere to good clinical practices during a bioavailability/bioequivalence clinical study.
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