# FDA 483 - Actavis Elizabeth LLC, A Company of Teva - April 26, 2011

Source: https://www.keypedia.com/records/483/actavis-elizabeth-llc-a-company-of-teva/86ad44f9-5029-4135-a3e8-50e2328be147

> FDA 483 for Actavis Elizabeth LLC, A Company of Teva on April 26, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Actavis Elizabeth LLC, A Company of Teva
- Inspection Date: 2011-04-26
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: The FDA inspection of Actavis Elizabeth LLC in Elizabeth, NJ, revealed significant deficiencies in their adverse drug experience reporting system. The firm failed to promptly review adverse event information and submit serious and unexpected adverse drug experience reports to the FDA within the required 15-day timeframe. Additionally, critical written procedures for post-marketing surveillance, evaluation, and training related to adverse drug experiences were not established.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
- [Erin McCaffery](https://www.keypedia.com/people/erin-mccaffery/5c6c37d3-99ab-47bc-a36b-b9b2417a26da)
- [issuing_officer](https://www.keypedia.com/people/stephen-j-mottola/a35bf779-9edb-40a3-93c8-1ac43808dccf)
- [Liatte Krueger](https://www.keypedia.com/people/liatte-krueger/cbfda638-7610-43d9-9301-2e010665c86d)

Company: https://www.keypedia.com/companies/actavis-elizabeth-llc-a-company-of-teva/c4a12fda-d6c3-4ad3-bac5-cc2b5695950e

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248