FDA 483 - Actavis Laboratories FL, Inc. - July 19, 2018

The FDA inspected Actavis Laboratories FL, Inc. in Davie, FL, and found significant deficiencies in their quality control unit, production, and process controls, particularly concerning laser drilling operations for extended-release tablets. These issues resulted in undrilled or incorrectly drilled tablets, dissolution failures, and product recalls, indicating a severe lack of oversight and control over critical manufacturing processes. The firm also demonstrated inadequate investigation practices, calibration procedures, and personnel training, posing a risk to drug product quality and patient safety.