# FDA 483 - Image Monitoring USA Inc. - February 06, 2020

Source: https://www.globalkeysolutions.net/records/483/image-monitoring-usa-inc/be951680-af5e-412e-9c54-a7ff89d83d08

> FDA 483 for Image Monitoring USA Inc. on February 06, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Image Monitoring USA Inc.
- Inspection Date: 2020-02-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Image Monitoring USA Inc. in Buffalo, NY, a medical device initial importer, revealed significant deficiencies in their quality management system. Observations included inadequate procedures for supplier quality management, insufficient document control practices, and a complete lack of documented personnel training records. These issues indicate a fundamental breakdown in maintaining compliance with regulatory requirements for medical device operations.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/image-monitoring-usa-inc/643502e8-b114-4dde-8dc7-279c1cb9375f

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961