Company
United StatesDentsply IH, Inc., Waltham, MA – FDA Inspections
Inspection records and compliance data for Dentsply IH, Inc. in Waltham, Massachusetts. 4 FDA inspections on record, 1 Form 483, last inspected August 30, 2018.
Company Profile
This profile covers Dentsply IH, Inc. based in Waltham, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 15, 2012. Last inspected August 30, 2018.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 30, 2018 | Not classified | Medical Devices & Rad Health | 1141451 |
| January 11, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 997615 |
| September 3, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 945200 |
| March 15, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 775121 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Dentsply IH, Inc.
FEI Number
1000120733
Address
590 Lincoln St, Waltham, Massachusetts 02451, United States
Country
United States
ID: ae66decb-0d21-41f5-a78d-2328949b9098