# FDA 483 - Integrated Orbital Implants Inc. - December 09, 2022

Source: https://www.keypedia.com/records/483/integrated-orbital-implants-inc/f0f77029-2c7c-486f-ba6b-ca9be0df55ab

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

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## Details

- Record Type: 483
- Company Name: Integrated Orbital Implants Inc.
- Inspection Date: 2022-12-09
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Integrated Orbital Implants Inc. in San Diego, CA, a specification developer of orbital implants, received nine observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality system, including inadequate complaint handling, ineffective corrective and preventive actions, and poor document and supplier controls. These findings indicate a broad failure to maintain a compliant quality system for medical device manufacturing.

## Related Officers

- [investigator](https://www.keypedia.com/people/elizabeth-a-dakan/f701338d-0484-431b-8bd5-9db442b5f079)

Company: https://www.keypedia.com/companies/integrated-orbital-implants-inc/2983796d-158a-456a-b17d-538297f3692d

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