# Resilience US, Inc. – FDA 483, Aug 11, 2017

Source: https://www.keypedia.com/records/483/resilience-us-inc/a20bea5b-9cb0-4b1f-a460-c7e9c48c30a4

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

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## Details

- Record Type: 483
- Company Name: Resilience US, Inc.
- Inspection Date: 2017-08-11
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- 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.

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## Related Officers

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

Company: https://www.keypedia.com/companies/resilience-us-inc/f20c4d81-432a-4fb6-9e24-c920285d7419

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