# FDA 483 - Genzyme Corporation - July 25, 2022

Source: https://www.keypedia.com/records/483/genzyme-corporation/349b695a-f390-44c5-b321-aa0f01ee5183

> FDA 483 for Genzyme Corporation on July 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genzyme Corporation
- Inspection Date: 2022-07-25
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Genzyme Corporation in Framingham, MA, revealed significant deficiencies in the manufacture of Thyrogen bulk drug substance. Observations included inadequate controls over computerized systems, leading to unreviewed audit trails and omitted data, as well as poor facility maintenance with issues like rust, chipped floors, and leaks in manufacturing areas. These findings indicate a lack of control over critical manufacturing processes and environmental conditions.

## Related Documents

- [483 - 2020-09-04](https://www.keypedia.com/records/483/genzyme-corporation/92fb5a72-64b2-4547-a360-5fbd53dbb20b)
- [483 - 2024-07-09](https://www.keypedia.com/records/483/genzyme-corporation/5b6ddbd8-75e1-4493-89cc-36eb3e3200af)
- [WARNING_LETTER - 2024-07-09](https://www.keypedia.com/records/warning_letter/genzyme-corporation/8a3ec574-4474-4308-b227-407524c4d420)

## Related Officers

- [Sean Morrissey](https://www.keypedia.com/people/sean-morrissey/03b79557-d733-468f-a0d7-a843d5d229a8)
- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94