# FDA 483 - Lummacups LLC - January 19, 2023

Source: https://www.keypedia.com/records/483/lummacups-llc/8866350f-92b2-4d2f-a8d3-1826afcf048e

> FDA 483 for Lummacups LLC on January 19, 2023. Product: devices. 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: devices
- Office Name: Office of Compliance Intervention and Consultation
- Summary: During an FDA inspection conducted on January 18-19, 2023, Lummcups LLC, a medical device specification developer, received an FDA Form 483 citing significant deficiencies in its quality management system. The inspection revealed a pervasive lack of established and documented procedures critical for ensuring product quality and regulatory compliance. Specifically, investigators observed that Lummcups LLC had not established written procedures for design control, including a complete design history file in English, despite having design records in Portuguese. Furthermore, the firm lacked documented procedures for corrective and preventive actions (CAPA), purchasing controls (including supplier audits and quality agreements), management reviews, and internal quality audits. This indicates a fundamental absence of foundational elements required for an effective quality system. These observations highlight non-compliance with essential FDA quality system regulations. Lummcups LLC is required to address these findings promptly and has promised to implement corrective actions for each identified deficiency to bring their operations into compliance with regulatory standards.

## Related Documents

- [483 - 2023-01-19](https://www.keypedia.com/records/483/lummacups-llc/cef4e1b2-4489-4e26-8788-069cf262c63e)

## Related Officers

- [Owner](https://www.keypedia.com/people/ronald-k-jones/e0331b37-a32b-420f-814d-c547b9e583a8)

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

Office: https://www.keypedia.com/offices/office-of-compliance-intervention-and-consultation/0b3cfe41-f423-41e0-b1a1-caab23b32d54