# FDA 483 - Hovione LLC - May 28, 2021

Source: https://www.globalkeysolutions.net/records/483/hovione-llc/18fc6b6f-89e5-47a6-8bf8-079e0a660ac4

> FDA 483 for Hovione LLC on May 28, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hovione LLC
- Inspection Date: 2021-05-28
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Hovione LLC in East Windsor, NJ, was inspected and received a Form 483 with eight observations primarily concerning manufacturing controls, laboratory practices, and quality system deficiencies. The inspection revealed issues with equipment maintenance, API testing, data integrity in laboratory records, adherence to production procedures, and inadequate investigation of quality incidents. Additionally, deficiencies were noted in employee GMP training and the warehousing and handling of raw materials.

## Related Documents

- [483 - 2020-01-22](https://www.globalkeysolutions.net/records/483/hovione-llc/bf3e5a4c-c97c-47b5-a056-b7191dbd2226)
- [483 - 2022-11-17](https://www.globalkeysolutions.net/records/483/hovione-llc/77ea7bfb-3801-42e1-97d6-451a5023c1fd)

## Related Officers

- [Stelios C Tsinontides](https://www.globalkeysolutions.net/people/stelios-c-tsinontides/7e17edef-7b2b-4d80-a2bf-58bd4e4ff658)
- [Annet R. Rajan](https://www.globalkeysolutions.net/people/annet-r-rajan/81b5a458-094f-48a5-839d-5c47b1a7c259)
- [Robin P. Mathew](https://www.globalkeysolutions.net/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)
- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

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