# FDA 483 - Hovione LLC - January 22, 2020

Source: https://www.keypedia.com/records/483/hovione-llc/bf3e5a4c-c97c-47b5-a056-b7191dbd2226

> FDA 483 for Hovione LLC on January 22, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hovione LLC
- Inspection Date: 2020-01-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Hovione LLC, a manufacturer of Intermediates and Active Pharmaceutical Ingredients in East Windsor, NJ, was cited for two significant observations. The inspection revealed inadequate employee training, which was identified as the root cause for a substantial number of quality-related events. Additionally, the firm failed to thoroughly review unexplained discrepancies, including the use of incorrect or expired solutions in analytical testing.

## Related Documents

- [483 - 2021-05-28](https://www.keypedia.com/records/483/hovione-llc/18fc6b6f-89e5-47a6-8bf8-079e0a660ac4)
- [483 - 2022-11-17](https://www.keypedia.com/records/483/hovione-llc/77ea7bfb-3801-42e1-97d6-451a5023c1fd)

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.keypedia.com/companies/hovione-llc/06b4417a-5377-4e73-8076-71d3066fa8f0

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