# Patheon Manufacturing Services LLC – FDA 483, May 19, 2026

Source: https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/5caebaaa-1e9b-45bd-ab94-25db51400b1d

> FDA 483 for Patheon Manufacturing Services LLC on May 19, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Manufacturing Services LLC
- Inspection Date: 2026-05-19
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: Patheon Manufacturing Services LLC in Ridgefield, NJ, a vaccine manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included a failure to establish specifications for yield determination, inadequate electronic data backup for critical fill parameters, and deficient aseptic gowning procedures allowing unqualified personnel in aseptic manufacturing areas. These issues indicate serious concerns regarding quality control and the prevention of microbiological contamination for sterile drug products.

## Related Documents

- [483 - 2024-08-30](https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/552e9a4d-ee76-4e72-a361-a56b2d900c30) — date: August 30, 2024
- [483 - 2024-03-18](https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/b8d19728-3c57-41fd-af77-18918dce4914) — date: March 18, 2024

## Related Officers

- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)
- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)

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