Company
United StatesSpectramed LLC, Columbus, OH – FDA Inspections
Inspection records and compliance data for Spectramed LLC in Columbus, Ohio. 4 FDA inspections on record, last inspected October 26, 2022.
Company Profile
This profile covers Spectramed LLC based in Columbus, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected May 7, 2009. Last inspected October 26, 2022.
Most cited issue areas
- Documented evaluation1 inspection
- Procedures not adequately established or maintained1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 26, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1182376 |
| December 11, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1114507 |
| July 23, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 840639 |
| May 7, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 579046 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Spectramed LLC
FEI Number
1000136007
Address
1601 Eastgate Pkwy, Columbus, Ohio 43230, United States
Country
United States
ID: 6cd71eb5-3aa5-4e94-ac4f-d13b815d2ced