# FDA 483 - Patheon Biologics (NJ) LLC - June 20, 2018

Source: https://www.keypedia.com/records/483/patheon-biologics-nj-llc/518e46d1-2060-4e2b-bfd8-2cc2cbffdc18

> FDA 483 for Patheon Biologics (NJ) LLC on June 20, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Biologics (NJ) LLC
- Inspection Date: 2018-06-20
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Patheon Biologics (NJ) LLC in Princeton, New Jersey, revealed two significant observations related to their laboratory and quality systems. The firm was cited for inadequate control of electronic laboratory data to prevent alteration or deletion, and for lacking written responsibilities and procedures for its quality control unit, including an enterprise-wide quality policy.

## Related Officers

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

Company: https://www.keypedia.com/companies/patheon-biologics-nj-llc/5d009aee-a952-4eee-a975-1b2bd0559e04

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