# FDA 483 - Actavis Laboratories UT, Inc. - March 19, 2024

Source: https://www.keypedia.com/records/483/actavis-laboratories-ut-inc/30da6e40-2e6e-45aa-88f1-15bfb9f5e13a

> FDA 483 for Actavis Laboratories UT, Inc. on March 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Actavis Laboratories UT, Inc.
- Inspection Date: 2024-03-19
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Actavis Laboratories UT, Inc. in Salt Lake City, UT, revealed significant deficiencies in facility maintenance, environmental monitoring, and quality control. The firm failed to maintain clean and sanitary manufacturing areas, exhibited inadequate environmental monitoring and cleaning validation, and demonstrated failures in laboratory investigation and CAPA effectiveness. These issues indicate a lack of robust control over drug manufacturing processes, particularly for Lidocaine Topical 5% Patch.

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## Related Officers

- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)
- [Joan M. Cantellops Figueroa](https://www.keypedia.com/people/joan-m-cantellops-figueroa/f791fcd2-a5d4-41e8-a8f2-96569096b422)

Company: https://www.keypedia.com/companies/actavis-laboratories-ut-inc/cbe6c043-14c7-4f58-84bf-68647da581f8

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face