# FDA 483 - Synovo Production, Inc. - October 02, 2023

Source: https://www.keypedia.com/records/483/synovo-production-inc/eb3a2dd7-d91b-4862-9bea-33cc22646fe5

> FDA 483 for Synovo Production, Inc. on October 02, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synovo Production, Inc.
- Inspection Date: 2023-10-02
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Synovo Production, Inc. in Fullerton, CA, received a Form FDA 483 with five observations following an inspection from September 8 to October 2, 2023. The inspection revealed significant deficiencies in quality system documentation, including undocumented process validation, lack of a design history file, inadequate CAPA documentation, and insufficient supplier qualification. Additionally, the firm failed to document personnel training, with several observations being repeats from a previous Warning Letter.

## 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/6490e21b-9575-4289-afcb-99b8a9fde9c9

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