FDA Inspection
ZOLL Medical CorporationZOLL Medical Corporation – FDA Inspection, Sep 14, 2009
Record Details
This FDA Inspection record concerns ZOLL Medical Corporation, with an inspection on September 14, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ZOLL Medical Corporation
- Inspection Date
- September 14, 2009
- Product Type
- Devices
View Company Profile
ID · f57c913a-1e4a-4aa2-8362-a29d75772f1b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 612883
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)(5)Implementing changes
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ZOLL Medical Corporation
14| Date | Classification | Office | Project area |
|---|---|---|---|
| April 15, 2025 | OAI | New England District Office | Compliance: Medical Devices |
| October 18, 2016 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| August 26, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 8, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 7, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ZOLL Medical Corporation
- FDA Inspection 1246565 - 2025-04-15
- FDA Inspection 992399 - 2016-10-18
- FDA Inspection 982649 - 2016-08-26
- FDA Inspection 966609 - 2016-04-08
- FDA Inspection 900180 - 2014-08-07
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