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

Source: https://www.keypedia.com/records/483/actavis-laboratories-fl-inc/4ba52ce8-bb09-4f71-b537-691a47df8dc3

> FDA 483 for Actavis Laboratories FL, Inc. on July 19, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Actavis Laboratories FL, Inc.
- Inspection Date: 2018-07-19
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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Company: https://www.keypedia.com/companies/actavis-laboratories-fl-inc/6c959344-9e81-4c3c-9e6d-580e25151c7d

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6