FDA Inspection
Pac-dent International, Inc.Pac-dent International, Inc. – FDA Inspection, Mar 12, 2026
Record Details
This FDA Inspection record concerns Pac-dent International, Inc., with an inspection on March 12, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
- Company
- Pac-dent International, Inc.
- Inspection Date
- March 12, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · f673bae1-dd15-4d83-b1f7-57e55ee0c1a8
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1306960
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
2- 21 CFR 830.310(b)GUDID Information required for unique device identification.
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
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Other FDA inspections of Pac-dent International, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pac-dent International, Inc.
- FDA Inspection 982065 - 2016-07-11
- FDA Inspection 654128 - 2010-03-26
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