# ZOLL Medical Corporation – FDA 483, Mar 18, 2011

Source: https://www.keypedia.com/records/483/zoll-medical-corporation/4a56d5e9-8583-4f9b-b683-71de7f5eae98

> FDA 483 for ZOLL Medical Corporation on March 18, 2011. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZOLL Medical Corporation
- Inspection Date: 2011-03-18
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of ZOLL Medical Corporation in Chelmsford, MA, a medical device manufacturer, revealed significant deficiencies across multiple quality system areas. The firm failed to adequately validate device designs and software, manage corrective and preventive actions, and maintain an effective device tracking program. Additionally, issues were noted in complaint handling, training procedures, and control of non-conforming materials, including components related to a Class I Recall.

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## Related Officers

- [CSO at FDA](https://www.keypedia.com/people/justine-m-corson/5f6e4477-f060-47f1-9165-a63fd6a36226)
- [Ramon E. Martinez, Investigator](https://www.keypedia.com/people/ramon-e-martinez-investigator/bc9e2b94-689b-484c-9825-7008a21f9350)

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

Office: https://www.keypedia.com/offices/fda-district-office-stoneham-massachusetts/880e6c44-d8c6-449f-be9e-c459a23205d1