# FDA 483 - Zoll Medical Corporations - March 10, 2022

Source: https://www.globalkeysolutions.net/records/483/zoll-medical-corporations/c81e6aec-8acb-403a-93e8-0770295a7653

> FDA 483 for Zoll Medical Corporations on March 10, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zoll Medical Corporations
- Inspection Date: 2022-03-10
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Zoll Medical Corporations in Rumford, RI, was inspected and cited for significant deficiencies in its quality system. The inspection revealed failures in process validation, revalidation after equipment changes, control of non-conforming products, and supplier management. These issues indicate a lack of robust procedures and documentation practices across several critical manufacturing areas.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/zoll-medical-corporations/68240c2e-9a26-4d13-99a4-60d527940cda

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7