# FDA 483 - Actavis Laboratories FL, Inc. - January 17, 2020

Source: https://www.globalkeysolutions.net/records/483/actavis-laboratories-fl-inc/7e4f8db5-e212-457c-8eb7-38d9605b8d57

> FDA 483 for Actavis Laboratories FL, Inc. on January 17, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Actavis Laboratories FL, Inc.
- Inspection Date: 2020-01-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Actavis Laboratories FL, Inc. in Davie, FL, revealed significant deficiencies across its quality systems, facilities, equipment, and production controls. The firm failed to conduct timely investigations into deviations, maintain validated process hold times, provide adequate employee training, properly locate and qualify equipment, and ensure proper equipment calibration. These issues indicate a lack of control over manufacturing processes and potentially impact drug product quality.

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

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