Company
United StatesSiemens Healthcare Diagnostics, Inc., Tarrytown, NY – FDA Inspections
Inspection records and compliance data for Siemens Healthcare Diagnostics, Inc. in Tarrytown, New York. 9 FDA inspections on record (1 OAI), 1 Form 483, 2 warning letters, last inspected May 24, 2024.
Company Profile
This profile covers Siemens Healthcare Diagnostics, Inc. based in Tarrytown, New York, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 1
- VAI
- 1
- NAI
- 7
- Form 483s
- 1
- Warning letters
- 2
First inspected November 24, 2009. Last inspected May 24, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design input - review and approval1 inspection
- Design plans - Lack of or inadequate1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 24, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1230618 |
| March 30, 2022 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1167476 |
| March 12, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1141620 |
| May 31, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1012263 |
| September 19, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 896868 |
| March 13, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 827292 |
| December 29, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 762172 |
| August 9, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 741950 |
| November 24, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 638744 |
FDA documents
Warning Letters (2)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Siemens Healthcare Diagnostics, Inc.
FEI Number
2432235
Address
511 Benedict Ave, Tarrytown, New York 10591, United States
Country
United States
ID: edcf8312-14f0-41fb-a21f-77f1872bdc36