Company
United StatesDraeger Medical Systems, Inc., Andover, MA – FDA Inspections
Inspection records and compliance data for Draeger Medical Systems, Inc. in Andover, Massachusetts. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected November 27, 2024.
Company Profile
This profile covers Draeger Medical Systems, Inc. based in Andover, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 11, 2009. Last inspected November 27, 2024.
Most cited issue areas
- Design validation - software validation not performed1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 27, 2024 | Not classified | Medical Devices & Rad Health | 1256505 |
| April 21, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1167843 |
| September 20, 2019 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1109645 |
| April 12, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 827184 |
| December 11, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 635977 |
FDA documents
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Company Information
Name
Draeger Medical Systems, Inc.
FEI Number
3005783425
Address
6 Tech Dr, Andover, Massachusetts 01810, United States
Country
United States
ID: 361285bb-e4c9-4778-bd58-59caf9885b61