# First Source Inc – FDA 483, Jun 24, 2026

Source: https://www.keypedia.com/records/483/first-source-inc/245e4908-9dd3-4cb0-8a8a-f89e8c26983b

> FDA 483 for First Source Inc on June 24, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: First Source Inc
- Inspection Date: 2026-06-24
- Product Type: device
- Office Name: New York District Office
- Summary: First Source, Inc., a medical device manufacturer in Rochester, NY, received a Form FDA-483 citing significant deficiencies in its quality system. The inspection revealed inadequate documentation for design and development changes, ineffective corrective and preventive action procedures, and poorly defined risk management processes. These issues indicate a need for improved quality system controls to ensure product safety and compliance.

## Related Documents

- [483 - 2023-09-19](https://www.keypedia.com/records/483/first-source-inc/f11e3a07-0315-458f-b810-56058bebe27d) — date: September 19, 2023
- [483 - 2021-07-20](https://www.keypedia.com/records/483/first-source-inc/62211af7-cd9e-49ec-a5d9-7496cd3a0adc) — date: July 20, 2021

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/first-source-inc/3da5a315-b5d8-4474-9a29-1373a3344a4b

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d