# FDA 483 - Aerin Medical, Inc. - September 22, 2025

Source: https://www.globalkeysolutions.net/records/483/aerin-medical-inc/a8214282-7ef3-44a3-af3e-4bc0de478fd7

> FDA 483 for Aerin Medical, Inc. on September 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aerin Medical, Inc.
- Inspection Date: 2025-09-22
- Product Type: device
- Office Name: San Francisco District Office
- Summary: Aerin Medical, Inc. in Mountain View, CA, a specification developer, was cited for two observations during an FDA inspection. The firm's corrective and preventive action (CAPA) system was found inadequate in preventing the recurrence of late Medical Device Reports (MDRs). Additionally, the inspection revealed deficiencies in personnel training documentation, with one marketing employee's training file missing.

## Related Officers

- [Brittany D. Mccracken](https://www.globalkeysolutions.net/people/brittany-d-mccracken/a869ecee-3b7b-4c1a-8c77-7efb1a3d902a)

Company: https://www.globalkeysolutions.net/companies/aerin-medical-inc/77377dad-3be0-4381-8706-9250c94a29e3

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df