# FDA 483 - ACI Medical LLC - August 17, 2023

Source: https://www.keypedia.com/records/483/aci-medical-llc/13fb6813-1d1b-48fc-ae15-ebedf26508e8

> FDA 483 for ACI Medical LLC on August 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ACI Medical LLC
- Inspection Date: 2023-08-17
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: ACI Medical LLC, a Class II medical device manufacturer in San Marcos, CA, was inspected by the FDA. The inspection revealed two significant quality system deficiencies related to the maintenance of device records. Specifically, the firm failed to maintain a complete device master record with adequate soldering procedures and did not include unique device identifiers in its device history records for ArtAssist devices.

## Related Officers

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

Company: https://www.keypedia.com/companies/aci-medical-llc/e8795739-867e-40ad-a58f-ceb7c5d37484

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