# FDA 483 - Genzyme Corporation - July 09, 2024

Source: https://www.keypedia.com/records/483/genzyme-corporation/5b6ddbd8-75e1-4493-89cc-36eb3e3200af

> FDA 483 for Genzyme Corporation on July 09, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genzyme Corporation
- Inspection Date: 2024-07-09
- Product Type: biologics
- Office Name: New England District Office
- Summary: Genzyme Corporation in Framingham, MA, a human biologic drug substance manufacturer, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant issues including inadequate investigation of deviations, inability to demonstrate reproducible manufacturing processes, poorly designed equipment, and a quality unit failing to ensure CGMP compliance. Additionally, the firm failed to follow production procedures and maintain clean facilities and equipment, indicating systemic control deficiencies.

## Related Documents

- [483 - 2020-09-04](https://www.keypedia.com/records/483/genzyme-corporation/92fb5a72-64b2-4547-a360-5fbd53dbb20b)
- [483 - 2022-07-25](https://www.keypedia.com/records/483/genzyme-corporation/349b695a-f390-44c5-b321-aa0f01ee5183)
- [WARNING_LETTER - 2024-07-09](https://www.keypedia.com/records/warning_letter/genzyme-corporation/8a3ec574-4474-4308-b227-407524c4d420)

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

Company: https://www.keypedia.com/companies/genzyme-corporation/b597b205-d758-426b-bc64-09970b3a1b83

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