# FDA 483 - Corindus Inc - July 27, 2021

Source: https://www.keypedia.com/records/483/corindus-inc/a6a1521b-13cb-4db4-b85c-c76a845c1082

> FDA 483 for Corindus Inc on July 27, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corindus Inc
- Inspection Date: 2021-07-27
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Corindus Inc, a medical device manufacturer in Waltham, MA, was inspected by the FDA from July 21-27, 2021. The inspection revealed significant deficiencies in the documentation of corrective and preventive action (CAPA) activities. Specifically, the firm failed to adequately document root cause analyses, investigations, and verification of effectiveness criteria for multiple CAPAs.

## Related Officers

- [company_representative](https://www.keypedia.com/people/david-j-sullivan/63b78401-cec1-4b9f-8617-256ad34551f5)
- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/corindus-inc/ffb424c0-20f8-4eb9-8691-a20af1f37533

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