# FDA 483 - Acutus Medical Inc - December 09, 2022

Source: https://www.keypedia.com/records/483/acutus-medical-inc/005bc9a5-06ee-4204-b8ef-588c30095115

> FDA 483 for Acutus Medical Inc on December 09, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acutus Medical Inc
- Inspection Date: 2022-12-09
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Acutus Medical Inc in Carlsbad, CA, from December 5-9, 2022, revealed four significant quality system deficiencies. The firm failed to adequately validate a critical manufacturing process, establish proper procedures for monitoring and controlling validated processes, and ensure adequate complaint handling procedures. Additionally, procedures to prevent contamination in the clean room were found to be insufficient.

## Related Officers

- [Kelvin Cheung](https://www.keypedia.com/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.keypedia.com/companies/acutus-medical-inc/41ea5e7d-4c13-4ce4-a94e-48d625b5fe34

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6