# FDA 483 - Zoll Medical Corporation - January 26, 2024

Source: https://www.keypedia.com/records/483/zoll-medical-corporation/16d96573-dcb4-4669-9b08-8b69ac901a83

> FDA 483 for Zoll Medical Corporation on January 26, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zoll Medical Corporation
- Inspection Date: 2024-01-26
- Product Type: device
- Office Name: Division of West Coast Imports
- Summary: Zoll Medical Corporation in Bothell, WA, was inspected by the FDA, resulting in three observations. The inspection revealed deficiencies in the firm's quality system, specifically concerning corrective and preventive actions, complaint handling procedures, and the maintenance of device history records. These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing.

## Related Officers

- [Kaitlyn E. Walsh](https://www.keypedia.com/people/kaitlyn-e-walsh/2a3d54f1-ff36-4abd-b1da-c153ff8b5893)
- [Michael J. Babich](https://www.keypedia.com/people/michael-j-babich/25eb940b-5cec-4b63-8957-6ed8065b4949)

Company: https://www.keypedia.com/companies/zoll-medical-corporation/cf747c7d-bb5c-4c62-8512-98b5ae3efdf0

Office: https://www.keypedia.com/offices/division-of-west-coast-imports/1d18f5f1-0b3b-4fe0-90f2-5cdf88b49268