# FDA 483 - Genzyme Corporation - March 18, 2024

Source: https://www.globalkeysolutions.net/records/483/genzyme-corporation/b8d19728-3c57-41fd-af77-18918dce4914

> FDA 483 for Genzyme Corporation on March 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

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

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

Company: https://www.globalkeysolutions.net/companies/genzyme-corporation/a58b7a37-69a3-45d1-a590-72294e5e7a17

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