# FDA 483 - 180 Innovations LLC - January 29, 2020

Source: https://www.keypedia.com/records/483/180-innovations-llc/e7275a2b-6c46-4d37-8d96-eb02954bde41

> FDA 483 for 180 Innovations LLC on January 29, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: 180 Innovations LLC
- Inspection Date: 2020-01-29
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of 100 Innovations LLC, a repackager/relabeler in Lakewood, CO, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures and documentation for complaint handling, rework of nonconforming products, statistical techniques for process control, and device history records. These issues indicate a systemic lack of adherence to quality system regulations.

## Related Documents

- [EIR - 2020-01-29](https://www.keypedia.com/records/eir/180-innovations-llc/3f0273fd-85e2-4a69-aaa4-e945569a3a38)

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/180-innovations-llc/c008b43b-67f6-488a-8952-755d0ea644c7

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face