Company
United StatesPrime Dental Manufacturing, Inc., Chicago, IL – FDA Inspections
Inspection records and compliance data for Prime Dental Manufacturing, Inc. in Chicago, Illinois. 4 FDA inspections on record, 1 Form 483, last inspected November 21, 2019.
Company Profile
This profile covers Prime Dental Manufacturing, Inc. based in Chicago, Illinois, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected December 22, 2008. Last inspected November 21, 2019.
Most cited issue areas
- Acceptance records1 inspection
- Implementing Personnel Procedures, Health, Cleanliness.1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 21, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1110626 |
| December 13, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 995381 |
| June 25, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 837689 |
| December 22, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 554863 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Premier Dental Products Company, Inc.
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Company Information
Name
Prime Dental Manufacturing, Inc.
FEI Number
3002811563
Address
4555 W Addison St, Chicago, Illinois 60641, United States
Country
United States
ID: 04ab8b5d-3944-4254-b935-900cc889ccb4