# FDA 483 - Lifesignals Inc - May 21, 2025

Source: https://www.globalkeysolutions.net/records/483/lifesignals-inc/9c22dbf1-0b1b-45fb-b25d-187c1c5f85ab

> FDA 483 for Lifesignals Inc on May 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lifesignals Inc
- Inspection Date: 2025-05-21
- Product Type: device
- Office Name: San Francisco District Office
- Summary: Lifesignals Inc. in Milpitas, CA, a specification developer, was cited for two observations related to its quality system. The firm's medical device reporting (MDR) procedure was found inadequate for timely event identification and evaluation, potentially leading to incorrect reportability decisions. Additionally, complaint handling procedures were not adequately established, specifically regarding investigation documentation and review of quality records.

## Related Officers

- [Nga T. Ho](https://www.globalkeysolutions.net/people/nga-t-ho/7c7d96a2-9b2c-4966-8dc2-ee20ca024be1)

Company: https://www.globalkeysolutions.net/companies/lifesignals-inc/043852c7-5757-4b14-9734-82ff2d4c9988

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