# FDA 483 - Resilience Boston Inc. - August 11, 2017

Source: https://www.globalkeysolutions.net/records/483/resilience-boston-inc/a20bea5b-9cb0-4b1f-a460-c7e9c48c30a4

> FDA 483 for Resilience Boston Inc. on August 11, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resilience Boston Inc.
- Inspection Date: 2017-08-11
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Sanofi Genzyme's drug substance manufacturing facility in Allston, MA, revealed significant deficiencies. Observations included inadequate cleaning validation for product contact parts, failures in the quality unit to ensure proper material testing and accurate reporting, and insufficient investigations into environmental microbial excursions. These issues indicate a lack of robust control over critical manufacturing processes and quality oversight.

## Related Documents

- [483 - 2008-10-10](https://www.globalkeysolutions.net/records/483/resilience-boston-inc/d15a0fc2-9592-4783-a8f6-b356057855b5)
- [483 - 2009-11-13](https://www.globalkeysolutions.net/records/483/resilience-boston-inc/444b2fce-fcd8-45a3-96b2-d6e74310afca)
- [483 - 2008-10-10](https://www.globalkeysolutions.net/records/483/resilience-boston-inc/8594c4c3-52f7-4830-b4df-f5fb58d1730c)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)
- [Diane Raccasi](https://www.globalkeysolutions.net/people/diane-raccasi/5c51bbf4-9c91-49c5-a1a5-d5aa7374890b)

Company: https://www.globalkeysolutions.net/companies/resilience-boston-inc/f20c4d81-432a-4fb6-9e24-c920285d7419

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7