Company
United StatesArchtek Dental, LLC, Carmel, IN – FDA Inspections
Inspection records and compliance data for Archtek Dental, LLC in Carmel, Indiana. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected October 25, 2018.
Company Profile
This profile covers Archtek Dental, LLC based in Carmel, Indiana, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 2, 2011. Last inspected October 25, 2018.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
- Complaints1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 25, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1072029 |
| January 26, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 765034 |
| June 2, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 728178 |
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
Archtek Dental, LLC
FEI Number
3000203342
Address
11405 Pennsylvania St Ste 106, Carmel, Indiana 46032, United States
Country
United States
ID: 7a761ca2-1ef8-43fc-91cc-3dc99648e618