# FDA 483 - Happiest Baby, Inc - July 25, 2025

Source: https://www.keypedia.com/records/483/happiest-baby-inc/65051bc0-d2a7-42d5-9192-28cc5f4c6f67

> FDA 483 for Happiest Baby, Inc on July 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Happiest Baby, Inc
- Inspection Date: 2025-07-25
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Happiest Baby, Inc. in Los Angeles, CA, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection found issues across complaint handling, design change, design validation, and corrective and preventive action procedures. These observations indicate a lack of robust controls for ensuring product safety and quality for their infant sleep systems.

## Related Documents

- [483 - 2025-07-25](https://www.keypedia.com/records/483/happiest-baby-inc/cee3152a-f767-4203-a9c8-3677cf9771b0)

## Related Officers

- [Jordan I. Abel](https://www.keypedia.com/people/jordan-i-abel/9cdc8877-ab20-4c0c-a17e-a8534d4f13f2)
- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/happiest-baby-inc/f2d4ec83-7f79-43dc-8a40-66a9e1bb507e

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