# FDA 483 - Novitium Pharma LLC - February 04, 2019

Source: https://www.keypedia.com/records/483/novitium-pharma-llc/0aefdaf2-ddff-41b3-ae7b-8d54b3c4dc1d

> FDA 483 for Novitium Pharma LLC on February 04, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Novitium Pharma LLC
- Inspection Date: 2019-02-04
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Novitium Pharma, Inc. in East Windsor, New Jersey, revealed significant deficiencies in their quality system and laboratory controls. Observations included inadequate assessment and control of changes to approved drug applications, as well as incomplete records for laboratory reference standards. These findings indicate systemic issues with the firm's quality unit procedures and documentation practices.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/novitium-pharma-llc/05f2c6f1-98bf-4208-b8d2-b177728a31dd)
- [483 - 2021-07-08](https://www.keypedia.com/records/483/novitium-pharma-llc/b16de3cf-1caa-4907-8ed7-1f90eadec551)

## Related Officers

- [Advisor](https://www.keypedia.com/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)

Company: https://www.keypedia.com/companies/novitium-pharma-llc/056d60b0-f42a-4b34-987f-749ffff0520a

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