# FDA 483 - Livongo Health, Inc. - November 28, 2018

Source: https://www.keypedia.com/records/483/livongo-health-inc/313788d1-980a-430b-b374-cb70a366059f

> FDA 483 for Livongo Health, Inc. on November 28, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Livongo Health, Inc.
- Inspection Date: 2018-11-28
- Product Type: device
- Office Name: Chicago District Office
- Summary: Chicago Health, Inc., a medical device manufacturer in Chicago, IL, received a Form FDA-483 for significant quality system deficiencies. The firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements, including issues with supplier quality agreements and review of device history records. Additionally, the company did not fully document corrective and preventive action activities related to various product defects.

## Related Documents

- [483 - 2016-02-04](https://www.keypedia.com/records/483/livongo-health-inc/51be1513-e77c-4d20-9f2d-d8dfa1ca1f24)

## Related Officers

- [Brittani N. Franklin](https://www.keypedia.com/people/brittani-n-franklin/1d5e9344-1145-42ff-a175-5541b565b15e)
- [Natasha R. Johnson](https://www.keypedia.com/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

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

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