# FDA 483 - Zoe Medical Incorporated - September 20, 2019

Source: https://www.keypedia.com/records/483/zoe-medical-incorporated/436bdd43-8fbe-4853-be83-6657dd43d01c

> FDA 483 for Zoe Medical Incorporated on September 20, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zoe Medical Incorporated
- Inspection Date: 2019-09-20
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Zoe Medical Incorporated, a medical device manufacturer in Topsfield, MA, was inspected by the FDA. The inspection revealed one observation concerning the lack of documented evaluation for a critical component supplier for their Class II medical device, the 740 Select Multi-Parameter Monitor. This indicates a deficiency in their quality system regarding supplier control.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/zoe-medical-incorporated/b005984a-65d6-45a1-a312-507b883f836a

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94