Company
United States21st Century Scientific Inc, Coeur d Alene, ID – FDA Inspections
Inspection records and compliance data for 21st Century Scientific Inc in Coeur d Alene, Idaho. 5 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected September 17, 2021.
Company Profile
This profile covers 21st Century Scientific Inc based in Coeur d Alene, Idaho, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 1
First inspected October 29, 2008. Last inspected September 17, 2021.
Most cited issue areas
- Calibration procedures - content1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documented evaluation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 17, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1151898 |
| September 12, 2018 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1066564 |
| March 21, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1007072 |
| July 13, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 736167 |
| October 29, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 547939 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
21st Century Scientific Inc
FEI Number
1000125727
Address
4931 N Manufacturing Way, Coeur d Alene, Idaho 83815, United States
Country
United States
ID: 817a7c04-70de-4053-bbb3-be76a2925b4a