Company
United StatesCambridge Heart, Inc., Wilmington, MA – FDA Inspections
Inspection records and compliance data for Cambridge Heart, Inc. in Wilmington, Massachusetts. 3 FDA inspections on record, last inspected March 04, 2013.
Company Profile
This profile covers Cambridge Heart, Inc. based in Wilmington, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected March 18, 2009. Last inspected March 4, 2013.
Most cited issue areas
- Approval, inadequate purchasing data1 inspection
- Complaints1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 4, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 820830 |
| March 3, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 712247 |
| March 18, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 572842 |
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
Cambridge Heart, Inc.
FEI Number
3000215432
Address
46 Jonspin Rd, Wilmington, Massachusetts 01887, United States
Country
United States
ID: 64664804-7bb8-4709-9fba-f08ad94c6eee