# FDA 483 - Synthasome, Inc - July 17, 2030

Source: https://www.keypedia.com/records/483/synthasome-inc/0e3f9988-8db2-422c-bac4-aca492528c5e

> FDA 483 for Synthasome, Inc on July 17, 2030. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synthasome, Inc
- Inspection Date: 2030-07-17
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Synthasome, Inc. in Del Mar, CA, was inspected by the FDA from July 17-18, 2023, revealing deficiencies in their quality system. The inspection found that procedures for design transfer were not adequately established or documented. This indicates a need for improved procedural definition and record-keeping, particularly concerning transfers to contract manufacturers.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/synthasome-inc/e664fac8-10f3-4b65-9a8b-654e6baff939

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