FDA Inspection
ZOLL Medical CorporationZOLL Medical Corporation – FDA Inspection, Apr 15, 2025
Record Details
This FDA Inspection record concerns ZOLL Medical Corporation, with an inspection on April 15, 2025, issued by the New England District Office, covering medical devices & rad health.
- Company
- ZOLL Medical Corporation
- Inspection Date
- April 15, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 15e80386-8d47-4fd7-a0a7-2a9d22433d20
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1246565
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ZOLL Medical Corporation
14| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| April 18, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ZOLL Medical Corporation
- FDA Inspection 992399 - 2016-10-18
- FDA Inspection 982649 - 2016-08-26
- FDA Inspection 966609 - 2016-04-08
- FDA Inspection 900180 - 2014-08-07
- FDA Inspection 875284 - 2014-04-18
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