Company
United StatesHeartware, Inc., Framingham, MA – FDA Inspections
Inspection records and compliance data for Heartware, Inc. in Framingham, Massachusetts. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected July 21, 2017.
Company Profile
This profile covers Heartware, Inc. based in Framingham, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected July 31, 2015. Last inspected July 21, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 21, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1020202 |
| July 31, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 940483 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Heartware, Inc.
FEI Number
3010767211
Address
500 Old Connecticut Path, Framingham, Massachusetts 01701, United States
Country
United States
ID: 3737dbe4-524b-4da4-b3bc-8c564221c1d4