# FDA 483 - Hovione LLC - November 17, 2022

Source: https://www.globalkeysolutions.net/records/483/hovione-llc/77ea7bfb-3801-42e1-97d6-451a5023c1fd

> FDA 483 for Hovione LLC on November 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hovione LLC
- Inspection Date: 2022-11-17
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Hovione LLC in East Windsor, NJ, from November 14-17, 2022, identified a significant issue with the calibration of mechanical equipment used in the manufacture of Trikafta Drug Product. The firm failed to perform routine calibration according to a written program, resulting in equipment being used outside its calibrated range or not on a routine schedule. This indicates a lapse in quality control over critical manufacturing processes.

## Related Documents

- [483 - 2020-01-22](https://www.globalkeysolutions.net/records/483/hovione-llc/bf3e5a4c-c97c-47b5-a056-b7191dbd2226)
- [483 - 2021-05-28](https://www.globalkeysolutions.net/records/483/hovione-llc/18fc6b6f-89e5-47a6-8bf8-079e0a660ac4)

## Related Officers

- [Pratibha Bhat](https://www.globalkeysolutions.net/people/pratibha-bhat/efadb9e5-642b-4085-aa0e-1bc118fd9a4f)
- [Robin P. Mathew](https://www.globalkeysolutions.net/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)
- [Adetutu M. Gidado](https://www.globalkeysolutions.net/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

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

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