# FDA 483 - Surgical Appliance Industries Inc - May 10, 2022

Source: https://www.keypedia.com/records/483/surgical-appliance-industries-inc/24a90268-92f3-4f1a-b21e-f6efb9e91e46

> FDA 483 for Surgical Appliance Industries Inc on May 10, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgical Appliance Industries Inc
- Inspection Date: 2022-05-10
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Surgical Appliance Industries Inc, a medical device manufacturer in Cincinnati, OH, was cited for multiple quality system deficiencies during an FDA inspection. Observations primarily focused on inadequate procedures and documentation for nonconforming product, device history records, labeling, CAPA, acceptance activities, equipment maintenance, and process controls, particularly concerning seaming operations. This indicates significant issues with their quality management system implementation.

## Related Documents

- [483 - 2023-10-18](https://www.keypedia.com/records/483/surgical-appliance-industries-inc/b7a425d6-b582-4d9d-b9b7-d4e3475738da)

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.keypedia.com/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)
- [Amber M. Capello-Jones](https://www.keypedia.com/people/amber-m-capello-jones/d34f92a0-d580-4028-9d31-c6cd7c13ce0f)

Company: https://www.keypedia.com/companies/surgical-appliance-industries-inc/ddca3396-15a4-4f97-8250-8f8d28af35e7

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22