Company
United StatesSiemens Healthcare Diagnostics, Inc., East Walpole, MA – FDA Inspections
Inspection records and compliance data for Siemens Healthcare Diagnostics, Inc. in East Walpole, Massachusetts. 8 FDA inspections on record (1 OAI), 2 Form 483s, last inspected March 08, 2022.
Company Profile
This profile covers Siemens Healthcare Diagnostics, Inc. based in East Walpole, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 4
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected March 24, 2009. Last inspected March 8, 2022.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Individual Report of Malfunction2 inspections
- Complaints1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 8, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1163970 |
| March 2, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1043709 |
| May 12, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1018565 |
| May 20, 2015 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 929757 |
| February 20, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 821920 |
| January 4, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 754929 |
| July 21, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 737289 |
| March 24, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 577341 |
FDA documents
Form 483s (2)
- Form 483s · March 8, 2022
- Form 483s · March 2, 2018
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Company Information
Name
Siemens Healthcare Diagnostics, Inc.
FEI Number
1219913
Address
333 Coney St, East Walpole, Massachusetts 02032, United States
Country
United States
ID: 2d2218be-bbbe-4685-81fc-9addbac958c7