# FDA 483 - NIMBLEHEART, INC - June 27, 2025

Source: https://www.globalkeysolutions.net/records/483/nimbleheart-inc/ddad5596-d82a-4a12-8db4-436ee56c5ba4

> FDA 483 for NIMBLEHEART, INC on June 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NIMBLEHEART, INC
- Inspection Date: 2025-06-27
- Product Type: device
- Office Name: San Francisco District Office
- Summary: NIMBLEHEART, INC in Sunnyvale, CA, a manufacturer of the Class 2 Physiotrace Smart System, was inspected by the FDA and received nine observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for design changes, corrective and preventive actions, complaint handling, management reviews, internal audits, product identification, non-conforming product control, supplier management, and equipment maintenance. These issues indicate a systemic failure to establish and maintain an effective quality system.

## Related Officers

- [Kenya Destin](https://www.globalkeysolutions.net/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)
- [Kevin T. Le](https://www.globalkeysolutions.net/people/kevin-t-le/cf8b5086-f585-4dd5-9f5c-f082b8a340f4)

Company: https://www.globalkeysolutions.net/companies/nimbleheart-inc/4dee0a03-c7b2-4f5e-b06a-6487bf6f767a

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df