Company
United StatesOhmeda Medical, Laurel, MD – FDA Inspections
Inspection records and compliance data for Ohmeda Medical in Laurel, Maryland. 5 FDA inspections on record, 1 Form 483, last inspected December 08, 2016.
Company Profile
This profile covers Ohmeda Medical based in Laurel, Maryland, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected August 24, 2009. Last inspected December 8, 2016.
Most cited issue areas
- Design validation - software validation not performed1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 8, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 994404 |
| June 19, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 929628 |
| May 6, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 830289 |
| June 18, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 787791 |
| August 24, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 606986 |
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
Ohmeda Medical
FEI Number
1121732
Address
8880 Gorman Rd, Laurel, Maryland 20723, United States
Country
United States
ID: ae48b221-3e5e-41a1-8e1e-909570786f0f