# FDA 483 - Lummacups LLC - January 19, 2023

Source: https://www.keypedia.com/records/483/lummacups-llc/cef4e1b2-4489-4e26-8788-069cf262c63e

> FDA 483 for Lummacups LLC on January 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lummacups LLC
- Inspection Date: 2023-01-19
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Lummaps LLC, a specification developer in Miami, FL, revealed a severe lack of fundamental quality system procedures. The firm failed to establish procedures for critical areas including design control, corrective and preventive actions, purchasing controls, management review, and internal quality audits. This indicates significant deficiencies in their quality management system.

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/lummacups-llc/ac9c6655-3ad2-44f4-a737-a1fc0c412dbe

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6