# Resilience US, Inc. – FDA 483, Oct 10, 2008

Source: https://www.keypedia.com/records/483/resilience-us-inc/d15a0fc2-9592-4783-a8f6-b356057855b5

> FDA 483 for Resilience US, Inc. on October 10, 2008. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resilience US, Inc.
- Inspection Date: 2008-10-10
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Genzyme Corporation in Allston, MA, revealed numerous deficiencies in drug manufacturing processes. Key issues included inadequate bioburden monitoring, poor control over batch production records, and insufficient documentation for manufacturing activities. The inspection also identified problems with aseptic processing qualification, equipment maintenance, and incomplete deviation files, indicating a broad lack of adherence to good manufacturing practices.

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## Related Officers

- [Marilyn Welzhenbach](https://www.keypedia.com/people/marilyn-welzhenbach/2649ccc4-9d0f-4e32-975b-9cf52500d4e1)
- [Jack Ragheb](https://www.keypedia.com/people/jack-ragheb/6e87a7a7-515d-42a2-9bc3-84c9d98b78a4)
- [Susan Kirshner](https://www.keypedia.com/people/susan-kirshner/a1fda890-508e-4137-8489-aab76371f504)
- [issuing_officer](https://www.keypedia.com/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)
- [Megan A. Haggerty](https://www.keypedia.com/people/megan-a-haggerty/029fddce-aa3a-4959-9c5e-4684603bbc50)

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