Company
United StatesPac-dent International, Inc., Brea, CA – FDA Inspections
Inspection records and compliance data for Pac-dent International, Inc. in Brea, California. 3 FDA inspections on record, 1 Form 483, last inspected March 12, 2026.
Company Profile
This profile covers Pac-dent International, Inc. based in Brea, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected March 26, 2010. Last inspected March 12, 2026.
Most cited issue areas
- GUDID Information required for unique device identification.1 inspection
- Records of supplier (re)evaluation, selection, and monitoring not maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 12, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1306960 |
| July 11, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 982065 |
| March 26, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 654128 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Pac-dent International, Inc.
FEI Number
3000719964
Address
670 Endeavor Cir, Brea, California 92821, United States
Country
United States
ID: f6addceb-f30b-424a-9c73-5b71ff849990