# FDA 483 - Resource Optimization & Innovation LLC - April 04, 2019

Source: https://www.keypedia.com/records/483/resource-optimization-innovation-llc/8614d287-a46f-474c-892c-e35f7e6b6e56

> FDA 483 for Resource Optimization & Innovation LLC on April 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resource Optimization & Innovation LLC
- Inspection Date: 2019-04-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Resource Optimization & Innovation, LLC. in Springfield, MO, a repackager/relabeler, was cited for significant deficiencies in its quality system related to medical device reporting and complaint handling. The firm's procedures for determining reportable events and timely MDR submission were inadequate, and numerous complaints were not processed within established timeframes or justified for extension. These issues indicate a lack of robust controls over critical post-market surveillance activities.

## Related Documents

- [483 - 2016-11-29](https://www.keypedia.com/records/483/resource-optimization-innovation-llc/91cab803-f072-4cee-9394-1e9f0554f56e)
- [UNTITLED_LETTER - 2018-07-13](https://www.keypedia.com/records/untitled_letter/resource-optimization-innovation-llc/dc33dbc8-1bd5-4248-9d9b-e820f502b2da)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/david-e-lowe/1a2492c2-4a81-4486-b3af-37f6b7b5216a)
- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/resource-optimization-innovation-llc/d9354f15-63a0-4635-a42b-3586044d38f3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8