# FDA 483 - First Source Inc - September 19, 2023

Source: https://www.keypedia.com/records/483/first-source-inc/f11e3a07-0315-458f-b810-56058bebe27d

> FDA 483 for First Source Inc on September 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: First Source Inc
- Inspection Date: 2023-09-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of First Source Inc. in Rochester, NY, a medical device manufacturer, identified seven observations related to their iQ Flex M Mobile X-ray System. The firm failed to establish and maintain adequate records for radiation safety testing and did not provide essential product information to purchasers. Additionally, deficiencies were noted in procedures for design changes, corrective and preventive actions, finished device acceptance, and control of nonconforming product.

## Related Documents

- [483 - 2021-07-20](https://www.keypedia.com/records/483/first-source-inc/62211af7-cd9e-49ec-a5d9-7496cd3a0adc)

## 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/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961