# FDA 483 - Domico Med-Device Llc - May 12, 2026

Source: https://www.keypedia.com/records/483/domico-med-device-llc/6c630ba4-24b2-45bc-9fd8-fc0a93eda9d6

> FDA 483 for Domico Med-Device Llc on May 12, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Domico Med-Device Llc
- Inspection Date: 2026-05-12
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: During an inspection, Domico Med-Device Llc in Fenton, MI, was cited for significant deficiencies across its quality system. Observations included inadequate risk management documentation, insufficient equipment calibration justifications, and gaps in complaint handling procedures. The firm also lacked proper qualification for production infrastructure and had deficiencies in its corrective and preventive action system, indicating a broad need for quality system improvements.

## Related Officers

- [investigator](https://www.keypedia.com/people/felicia-e-armbrustmacher/83e0f3f7-2bfc-4250-8627-76685eee6b03)

Company: https://www.keypedia.com/companies/domico-med-device-llc/a96d3c85-e474-46dc-a86f-629bf3588679

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0