# FDA 483 - Synovo Production, Inc. - October 26, 2022

Source: https://www.keypedia.com/records/483/synovo-production-inc/0e1325ea-2bf6-47f0-87e8-a83309c57359

> FDA 483 for Synovo Production, Inc. on October 26, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synovo Production, Inc.
- Inspection Date: 2022-10-26
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Synovo Production, Inc. in Fullerton, CA, a manufacturer of hip replacement systems, received a Form FDA 483 with seven observations following an inspection from October 11-26, 2022. The inspection revealed significant deficiencies in quality system procedures, including inadequate process validation, design change controls, CAPA effectiveness verification, supplier qualification documentation, management reviews, internal audits, and personnel training records. These issues indicate a systemic breakdown in maintaining a compliant quality management system for medical devices.

## Related Documents

- [483 - 2023-10-02](https://www.keypedia.com/records/483/synovo-production-inc/4ba867a0-325a-47bc-a639-a2532c84c8ad)

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/synovo-production-inc/11640fba-a47f-4d38-98b8-c4fef1debc61

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