# FDA 483 - Livongo Health, Inc. - February 04, 2016

Source: https://www.globalkeysolutions.net/records/483/livongo-health-inc/51be1513-e77c-4d20-9f2d-d8dfa1ca1f24

> FDA 483 for Livongo Health, Inc. on February 04, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Livongo Health, Inc.
- Inspection Date: 2016-02-04
- Product Type: device
- Office Name: Chicago District Office
- Summary: Livongo Health, Inc. in Chicago, IL was inspected from January 25 to February 4, 2016, and received two observations. The firm failed to report a device correction for its In Touch Test Strips to the FDA and lacked established procedures for corrective and preventive actions. These issues indicate significant deficiencies in quality system management and regulatory reporting.

## Related Documents

- [483 - 2018-11-28](https://www.globalkeysolutions.net/records/483/livongo-health-inc/313788d1-980a-430b-b374-cb70a366059f)

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/livongo-health-inc/551bdfa5-469d-43f5-9515-3934d51d1aca

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669