# FDA 483 - ZOLL Medical Corporation - April 15, 2025

Source: https://www.keypedia.com/records/483/zoll-medical-corporation/f9621e42-509e-46b0-9f73-5213f3182105

> FDA 483 for ZOLL Medical Corporation on April 15, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZOLL Medical Corporation
- Inspection Date: 2025-04-15
- Product Type: device
- Office Name: New England District Office
- Summary: ZOLL Medical Corporation in Chelmsford, MA, received a Form 483 with five observations highlighting significant deficiencies in their quality system. The inspection revealed inadequate procedures for design validation, corrective and preventive actions, risk analysis, and supplier management, leading to multiple product recalls, serious injuries, and deaths. Additionally, the firm failed to submit required Medical Device Reports (MDRs) for device malfunctions.

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.keypedia.com/companies/zoll-medical-corporation/2fa75f8a-9939-4cab-9706-0c64cb165b81

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144