Company
United StatesZOLL Medical Corporation, Chelmsford, MA – FDA Inspections
Inspection records and compliance data for ZOLL Medical Corporation in Chelmsford, Massachusetts. 15 FDA inspections on record (4 OAI), 2 Form 483s, last inspected April 15, 2025.
Company Profile
This profile covers ZOLL Medical Corporation based in Chelmsford, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 15
- OAI
- 4
- VAI
- 5
- NAI
- 6
- Form 483s
- 2
- Warning letters
- 0
First inspected September 14, 2009. Last inspected April 15, 2025.
Most cited issue areas
- Lack of or inadequate procedures4 inspections
- Design validation - user needs and intended uses3 inspections
- Lack of System for Event Evaluations2 inspections
FDA inspections (15)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 15, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1246565 |
| October 18, 2016 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 992399 |
| August 26, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 982649 |
| April 8, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 966609 |
| August 7, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 900180 |
| April 18, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 875284 |
| September 26, 2012 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 799758 |
| April 19, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 781953 |
| November 15, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 754520 |
| August 18, 2011 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 746520 |
| June 7, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 729955 |
| March 18, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 717161 |
| November 12, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 700035 |
| March 8, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 652203 |
| September 14, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 612883 |
FDA documents
Form 483s (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ZOLL Medical Corporation
FEI Number
1220908
Address
269 Mill Rd, Chelmsford, Massachusetts 01824, United States
Country
United States
ID: 2fa75f8a-9939-4cab-9706-0c64cb165b81