Company
United StatesKeystone Dental Inc, Burlington, MA – FDA Inspections
Inspection records and compliance data for Keystone Dental Inc in Burlington, Massachusetts. 3 FDA inspections on record, 1 Form 483, last inspected June 08, 2017.
Company Profile
This profile covers Keystone Dental Inc based in Burlington, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 12, 2012. Last inspected June 8, 2017.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Lack of System for Event Evaluations1 inspection
- Quality audits - auditor independence1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 8, 2017 | VAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 1014229 |
| October 7, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 851881 |
| October 12, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 797857 |
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
Keystone Dental Inc
FEI Number
3005990499
Address
154 Middlesex Tpke, Burlington, Massachusetts 01803, United States
Country
United States
ID: 6025d413-6f2b-4b7c-a40e-280ceb57ac72