Company
United StatesSiemens Healthcare Diagnostics Inc, Norwood, MA – FDA Inspections
Inspection records and compliance data for Siemens Healthcare Diagnostics Inc in Norwood, Massachusetts. 3 FDA inspections on record, last inspected August 19, 2021.
Company Profile
This profile covers Siemens Healthcare Diagnostics Inc based in Norwood, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 19, 2010. Last inspected August 19, 2021.
Most cited issue areas
- Individual Report of Malfunction2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 19, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1149882 |
| August 21, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 846920 |
| May 19, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 663938 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Siemens Healthcare Diagnostics Inc
FEI Number
3002637618
Address
2 Edgewater Dr, Norwood, Massachusetts 02062, United States
Country
United States
ID: 98bad44f-0277-4bb9-8dc4-fcf30af722a4