FDA Inspection
ZOLL Medical CorporationZOLL Medical Corporation – FDA Inspection, Jun 7, 2011
Record Details
This FDA Inspection record concerns ZOLL Medical Corporation, with an inspection on June 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ZOLL Medical Corporation
- Inspection Date
- June 7, 2011
- Product Type
- Devices
View Company Profile
ID · 2f90cae3-dc7a-4f55-9980-f9be88885f50
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 729955
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 821.25(c)(3)Quality assurance procedures: 6-month & annual audits
- 21 CFR 821.25(b)Records not current
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.