# FDA 483 - Syntron Bioresearch Inc - June 02, 2025

Source: https://www.globalkeysolutions.net/records/483/syntron-bioresearch-inc/5728b8e4-0e54-4216-8c09-3badd6f2e59b

> FDA 483 for Syntron Bioresearch Inc on June 02, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Syntron Bioresearch Inc
- Inspection Date: 2025-06-02
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Syntron Bioresearch Inc, a medical device manufacturer in Carlsbad, CA, received two observations during an FDA inspection. The firm failed to adequately establish procedures for controlling non-conforming products, which led to the release and subsequent recall of its "apphia The Baby Planning Bundle" kits. Additionally, the company has not maintained a device master record for its manufactured devices, indicating significant quality system deficiencies.

## Related Officers

- [Jenny L. Chisem](https://www.globalkeysolutions.net/people/jenny-l-chisem/d9c3fada-4f08-4f1a-9c6c-06a3c521534c)

Company: https://www.globalkeysolutions.net/companies/syntron-bioresearch-inc/b51f22f3-324e-46f7-a221-12bab9b1f9e8

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b