Pac-dent, Inc
FDA inspection history in Brea, California, 2026
- 1
- Form 483
Every document, by year
- Form 483
2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2026One Form 483, at Brea, California.
Cited most
Across all Pac-dent observations on file
- ISO 13485:2016 Clause 7.4.11
- 21 CFR 830.310(b)Information required for unique device identification1
The complete Pac-dent file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Brea, California
One Form 483 · 2026 · 2 observations
Latest: Form 483, Mar 12, 2026 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-12 | 483 Form 483 | Brea, California | 2 | $99 |
Investigators on these documents
FEI number 3000719964 · most recent document Mar 12, 2026
About Pac-dent, Inc
How many FDA Form 483s has Pac-dent, Inc received?
FDA Intel has 1 Form 483 on file for Pac-dent, Inc; the most recent is dated Mar 12, 2026.
When was Pac-dent, Inc last inspected by FDA?
The most recent FDA inspection document on file for Pac-dent, Inc is a Form 483 dated Mar 12, 2026, for the site in Brea, California.
What did FDA cite at Pac-dent, Inc?
The regulations cited most in the observations on file for Pac-dent, Inc are ISO 13485:2016 Clause 7.4.1, 1 time; 21 CFR 830.310(b) (Information required for unique device identification), 1 time.