# FDA 483 - Arch Medical Solutions - Escondido LLC - April 07, 2023

Source: https://www.keypedia.com/records/483/arch-medical-solutions-escondido-llc/ec961fb3-34b9-4747-813c-5616d0946bb7

> FDA 483 for Arch Medical Solutions - Escondido LLC on April 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arch Medical Solutions - Escondido LLC
- Inspection Date: 2023-04-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Arch Medical Solutions - Escondido LLC, a Class II medical device contract manufacturer, was inspected by the FDA. The inspection revealed a significant issue with the firm's complaint handling process, specifically the failure to properly evaluate and investigate complaints involving device, labeling, and packaging specifications. This indicates a serious lapse in quality system procedures.

## Related Officers

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

Company: https://www.keypedia.com/companies/arch-medical-solutions-escondido-llc/42ad40ca-5816-4c6a-99a9-f462b5fcc4e7

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