FDA Inspection
ZOLL Medical CorporationZOLL Medical Corporation – FDA Inspection, Mar 8, 2010
Record Details
This FDA Inspection record concerns ZOLL Medical Corporation, with an inspection on March 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ZOLL Medical Corporation
- Inspection Date
- March 8, 2010
- Product Type
- Devices
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ID · 7bfb49af-1ebf-43f5-9b30-15ef0a826a4c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 652203
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(d)Essential design outputs
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 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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