Company
United StatesSiemens Healthcare Diagnostics, Inc., Newark, DE – FDA Inspections
Inspection records and compliance data for Siemens Healthcare Diagnostics, Inc. in Newark, Delaware. 5 FDA inspections on record (1 OAI), last inspected May 14, 2024.
Company Profile
This profile covers Siemens Healthcare Diagnostics, Inc. based in Newark, Delaware, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 8, 2009. Last inspected May 14, 2024.
Most cited issue areas
- Documentation2 inspections
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 14, 2024 | Not classified | Medical Devices & Rad Health | 1278130 |
| April 23, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 875518 |
| December 17, 2012 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 813459 |
| February 9, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 768876 |
| May 8, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 585525 |
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
Siemens Healthcare Diagnostics, Inc.
FEI Number
2517506
Address
500 Gbc Dr, Newark, Delaware 19702, United States
Country
United States
ID: 847267c5-fd0d-4863-882c-b05658c0af10