# FDA 483 - Actavis Laboratories FL, Inc. - December 01, 2017

Source: https://www.globalkeysolutions.net/records/483/actavis-laboratories-fl-inc/464aa95a-8c29-407d-a49e-c70979c2693f

> FDA 483 for Actavis Laboratories FL, Inc. on December 01, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Actavis Laboratories FL, Inc.
- Inspection Date: 2017-12-01
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Actavis Laboratories, FL, Inc. in Sunrise, FL, a generic drug product manufacturer, revealed significant deficiencies in its packaging and labeling systems and quality control. Observations included the presence of foreign tablets in packaging areas after cleaning, instances of mislabeling and missing lot numbers on distributed products, and a failure to adequately investigate numerous consumer complaints regarding short-counts. These issues suggest a lack of robust controls to prevent product mix-ups and ensure product quality and quantity.

## Related Officers

- [Libia Lugo](https://www.globalkeysolutions.net/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

Company: https://www.globalkeysolutions.net/companies/actavis-laboratories-fl-inc/7c50db23-6cc7-4100-bc80-c02d3aa7f85a

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