# FDA 483 - CME America, LLC - April 23, 2018

Source: https://www.keypedia.com/records/483/cme-america-llc/5f321213-5720-49da-91b0-79715059f2cf

> FDA 483 for CME America, LLC on April 23, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CME America, LLC
- Inspection Date: 2018-04-23
- Product Type: device
- Office Name: Denver District Office
- Summary: CME America, LLC, a medical device manufacturer in Golden, CO, was inspected and found to have significant quality system deficiencies. The firm failed to adequately establish procedures for design verification and validation of its BodyGuard infusion pump system. Additionally, issues were noted in their corrective and preventive action processes and in ensuring purchased products and services conform to specified requirements.

## Related Officers

- [Kathleen S. Tormey](https://www.keypedia.com/people/kathleen-s-tormey/5e1abfe2-078a-4c61-bb98-3885f853a945)
- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/cme-america-llc/fc46915a-1261-48e7-a639-0e345874a64f

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