# FDA 483 - Flex Operating Room, LLC - June 18, 2019

Source: https://www.globalkeysolutions.net/records/483/flex-operating-room-llc/81adfd52-e3c0-4aa9-b846-f6f9087801d4

> FDA 483 for Flex Operating Room, LLC on June 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Flex Operating Room, LLC
- Inspection Date: 2019-06-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Flex Operating Room, LLC, a medical device specification developer in Pittsford, NY, revealed significant deficiencies in their quality system. The firm failed to establish numerous required procedures, including those for design control, quality audits, management review, CAPA, nonconforming product, document control, and training. These widespread procedural gaps indicate a fundamental lack of a robust quality system for medical device development.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/flex-operating-room-llc/60281d59-0f0c-441b-8369-034b143b73f0

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