# FDA 483 - 4QImaging, LLC DBA Qmetrics - February 04, 2019

Source: https://www.keypedia.com/records/483/4qimaging-llc-dba-qmetrics/34b936a4-2cc2-4634-ba10-1ac312bf5b38

> FDA 483 for 4QImaging, LLC DBA Qmetrics on February 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 4QImaging, LLC DBA Qmetrics
- Inspection Date: 2019-02-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 4QImaging, LLC DBA Qmetrics, a medical device manufacturer in Pittsford, NY, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked established written procedures for Medical Device Reporting (MDRs), handling customer complaints, and controlling non-conforming products. These observations indicate a fundamental failure to implement critical regulatory requirements for medical device manufacturing.

## Related Officers

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

Company: https://www.keypedia.com/companies/4qimaging-llc-dba-qmetrics/d594da16-46b7-471a-948d-b6f9a3a41367

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