# FDA 483 - Resilience Boston Inc. - October 10, 2008

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

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

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## Details

- Record Type: 483
- Company Name: Resilience Boston 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

- [Megan A. Haggerty](https://www.keypedia.com/people/megan-a-haggerty/029fddce-aa3a-4959-9c5e-4684603bbc50)
- [Marilyn Welzhenbach](https://www.keypedia.com/people/marilyn-welzhenbach/2649ccc4-9d0f-4e32-975b-9cf52500d4e1)
- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.keypedia.com/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)
- [Jack Ragheb](https://www.keypedia.com/people/jack-ragheb/6e87a7a7-515d-42a2-9bc3-84c9d98b78a4)
- [issuing_officer](https://www.keypedia.com/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

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

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