# FDA 483 - Genzyme Corporation - May 19, 2026

Source: https://www.keypedia.com/records/483/genzyme-corporation/5caebaaa-1e9b-45bd-ab94-25db51400b1d

> FDA 483 for Genzyme Corporation on May 19, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genzyme Corporation
- 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.

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## 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/genzyme-corporation/a58b7a37-69a3-45d1-a590-72294e5e7a17

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