# FDA 483 - Genzyme Corporation - February 14, 2025

Source: https://www.keypedia.com/records/483/genzyme-corporation/3adce78e-cce8-40f0-a243-541478a76c60

> FDA 483 for Genzyme Corporation on February 14, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genzyme Corporation
- Inspection Date: 2025-02-14
- Product Type: biologics
- Office Name: New England District Office
- Summary: An FDA inspection of Genzyme Corporation's Northborough, MA facility revealed three observations related to labeling, packaging, and quality control. The firm failed to follow procedures for correct drug product labeling, resulting in incorrect potency values printed on Altuviiio finished product. Additionally, examination of packaging materials was not adequately performed, and investigations into unexplained discrepancies were not consistently documented.

## Related Officers

- [investigator](https://www.keypedia.com/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)
- [FDA_PERSONNEL](https://www.keypedia.com/people/lizaida-perez/686fbdca-bfd7-4a73-990a-d8a97e6b88b7)

Company: https://www.keypedia.com/companies/genzyme-corporation/f157f5fd-aee3-4994-b098-37af3a503a02

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144