# FDA 483 - Corindus, Inc. - January 25, 2024

Source: https://www.keypedia.com/records/483/corindus-inc/bbe2e883-7fc9-4ba9-8ae9-e1c793b750a7

> FDA 483 for Corindus, Inc. on January 25, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corindus, Inc.
- Inspection Date: 2024-01-25
- Product Type: device
- Office Name: New England District Office
- Summary: Corindus, Inc. in Auburndale, MA, a manufacturer of the CorPath GRX System and Cassette, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, specifically concerning corrective and preventive actions (CAPA), complaint handling, and environmental controls for manufacturing. These issues indicate a lack of adherence to established procedures and proper documentation practices.

## Related Officers

- [Fouad Attioui](https://www.keypedia.com/people/fouad-attioui/640028ab-0cdd-43c8-816f-433f19c7ad3d)
- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/corindus-inc/6310565a-b5d5-46fb-b5cd-1e987672a90d

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144