# FDA 483 - Surgical Appliance Industries Inc - October 18, 2023

Source: https://www.globalkeysolutions.net/records/483/surgical-appliance-industries-inc/b7a425d6-b582-4d9d-b9b7-d4e3475738da

> FDA 483 for Surgical Appliance Industries Inc on October 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgical Appliance Industries Inc
- Inspection Date: 2023-10-18
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Surgical Appliance Industries Inc. in Cincinnati, OH, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for corrective and preventive actions, complaint handling, and control of nonconforming product. These issues, including repeat observations from a previous inspection, indicate a systemic lack of adherence to quality system requirements.

## Related Documents

- [483 - 2022-05-10](https://www.globalkeysolutions.net/records/483/surgical-appliance-industries-inc/24a90268-92f3-4f1a-b21e-f6efb9e91e46)

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.globalkeysolutions.net/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)

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

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