FDA Inspection
ZOLL Medical CorporationZOLL Medical Corporation – FDA Inspection, Mar 18, 2011
Record Details
This FDA Inspection record concerns ZOLL Medical Corporation, with an inspection on March 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ZOLL Medical Corporation
- Inspection Date
- March 18, 2011
- Product Type
- Devices
View Company Profile
ID · d46f6eab-3f76-4486-aaf5-a5b6a7e2dda0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 717161
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 821.25(a)Written tracking program
- 21 CFR 821.25(c)(3)Quality assurance procedures: 6-month & annual audits
- 21 CFR 803.18(e)MDR not evaluated per 820.198
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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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