# Patheon Manufacturing Services LLC – FDA 483, Mar 18, 2024

Source: https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/b8d19728-3c57-41fd-af77-18918dce4914

> FDA 483 for Patheon Manufacturing Services LLC on March 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Manufacturing Services LLC
- Inspection Date: 2024-03-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Genzyme Corporation in Ridgefield, NJ, a drug manufacturer, identified a significant issue regarding procedures to prevent microbiological contamination of sterile drug products. Specifically, the firm's smoke studies for the aseptic filling of Lovenox syringes were found to be inadequate, failing to demonstrate unidirectional airflow during critical interventions and assess observed air currents. This raises concerns about the sterility assurance of their products.

## Related Documents

- [483 - 2026-05-19](https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/5caebaaa-1e9b-45bd-ab94-25db51400b1d) — date: May 19, 2026
- [483 - 2024-08-30](https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/552e9a4d-ee76-4e72-a361-a56b2d900c30) — date: August 30, 2024

## Related Officers

- [Stephenie M. Ortiz](https://www.keypedia.com/people/stephenie-m-ortiz/b0923b14-b153-4893-8eb2-f5e6b1fd2041)
- [Paige R Moore](https://www.keypedia.com/people/paige-r-moore/cb4214c7-bfe1-4daf-bf85-fe9d26925a8d)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)
- [Annet R. Rajan](https://www.keypedia.com/people/annet-r-rajan/81b5a458-094f-48a5-839d-5c47b1a7c259)

Company: https://www.keypedia.com/companies/patheon-manufacturing-services-llc/a58b7a37-69a3-45d1-a590-72294e5e7a17

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