Company
United StatesGergens Orthodontic Lab, Inc., Phoenix, AZ – FDA Inspections
Inspection records and compliance data for Gergens Orthodontic Lab, Inc. in Phoenix, Arizona. 3 FDA inspections on record, 2 Form 483s, last inspected March 30, 2023.
Company Profile
This profile covers Gergens Orthodontic Lab, Inc. based in Phoenix, Arizona, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected August 9, 2013. Last inspected March 30, 2023.
Most cited issue areas
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of procedures, or not maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 30, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1201361 |
| May 16, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1052154 |
| August 9, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 847225 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Gergens Orthodontic Lab, Inc.
FEI Number
3008274496
Address
1745 W Deer Valley Rd Ste 112, Phoenix, Arizona 85027, United States
Country
United States
ID: 589139e3-62a4-4aca-95af-0a3c18e74b0a