# FDA 483 - Genzyme Corporation - March 18, 2026

Source: https://www.keypedia.com/records/483/genzyme-corporation/fc1a8bb7-0dda-4b46-8a2f-16f5eac5f139

> FDA 483 for Genzyme Corporation on March 18, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genzyme Corporation
- Inspection Date: 2026-03-18
- Product Type: biologics
- Office Name: New England District Office
- Summary: Genzyme Corporation in Framingham, MA, a biologic drug substance manufacturer, received a Form 483 with six observations. The inspection revealed significant issues including the release of drug substance with particle contamination, inadequate investigations into manufacturing deviations and cleaning failures, and deficiencies in equipment re-qualification. Additionally, the firm failed to follow adequate production control procedures, maintain equipment appropriately, and establish proper laboratory control mechanisms.

## Related Documents

- [EIR - 2022-06-25](https://www.keypedia.com/records/eir/genzyme-corporation/6eb86bff-8103-449e-b583-0fb676d5acb3)
- [EIR - 2020-09-04](https://www.keypedia.com/records/eir/genzyme-corporation/9e7a9f46-31eb-4d3b-9af7-a9f9dea767de)
- [483 - 2024-07-09](https://www.keypedia.com/records/483/genzyme-corporation/5b6ddbd8-75e1-4493-89cc-36eb3e3200af)
- [483 - 2020-09-04](https://www.keypedia.com/records/483/genzyme-corporation/92fb5a72-64b2-4547-a360-5fbd53dbb20b)
- [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