# FDA 483 - Genzyme Corporation - August 30, 2024

Source: https://www.keypedia.com/records/483/genzyme-corporation/552e9a4d-ee76-4e72-a361-a56b2d900c30

> FDA 483 for Genzyme Corporation on August 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genzyme Corporation
- Inspection Date: 2024-08-30
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Genzyme Corporation in Ridgefield, NJ, a drug product manufacturer, received a Form 483 with four observations detailing significant deficiencies. These include inadequate production and process controls for sterile injectable products, failures in preventing microbiological contamination during aseptic processing, insufficient investigation procedures for discrepancies, and a lack of adequate oversight by the Quality Unit. The findings indicate a systemic breakdown in quality assurance and control.

## Related Documents

- [483 - 2024-03-18](https://www.keypedia.com/records/483/genzyme-corporation/b8d19728-3c57-41fd-af77-18918dce4914)
- [483 - 2026-05-19](https://www.keypedia.com/records/483/genzyme-corporation/5caebaaa-1e9b-45bd-ab94-25db51400b1d)

## Related Officers

- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/ekaterina-allen/760a7817-8e5b-45f9-82ee-db6ca139a92e)

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