Company
United StatesZOLL Medical Corporation, Pawtucket, RI – FDA Inspections
Inspection records and compliance data for ZOLL Medical Corporation in Pawtucket, Rhode Island. 3 FDA inspections on record, 1 Form 483, last inspected October 25, 2017.
Company Profile
This profile covers ZOLL Medical Corporation based in Pawtucket, Rhode Island, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 2, 2011. Last inspected October 25, 2017.
Most cited issue areas
- Investigation of device failures3 inspections
- Lack of or inadequate procedures3 inspections
- Lack of or inadequate process validation2 inspections
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 25, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1029757 |
| July 11, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 885657 |
| December 2, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 755248 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ZOLL Medical Corporation
FEI Number
1218058
Address
525 Narragansett Park Dr, Pawtucket, Rhode Island 02861, United States
Country
United States
ID: 022a1afa-f78b-4353-8b2a-08fbfc95b78d