# FDA 483 - Intrinsic Therapeutics, Inc. - July 21, 2022

Source: https://www.keypedia.com/records/483/intrinsic-therapeutics-inc/c3b4d546-69df-48e9-ad34-f3f45fdf59a2

> FDA 483 for Intrinsic Therapeutics, Inc. on July 21, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Intrinsic Therapeutics, Inc.
- Inspection Date: 2022-07-21
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Intrinsic Therapeutics, Inc. in Woburn, MA, was cited for significant deficiencies in its corrective and preventive action (CAPA) procedures during an FDA inspection. The firm failed to consistently process recurring quality issues in a timely manner and conducted inadequate verification of CAPA effectiveness. These issues indicate a systemic problem in maintaining an effective quality system.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/matthew-w-kyle/0f297104-ae6c-4fc4-a240-c84e5e907803)

Company: https://www.keypedia.com/companies/intrinsic-therapeutics-inc/afa6ccba-7887-41a7-8002-836502144e76

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