Plasdent Corporation
FDA inspection history in Pomona, California, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Pomona, California.
Cited most
Across all Plasdent observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.120Device labeling1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.20(b)(3)Management responsibility1
The complete Plasdent file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Pomona, California
One Form 483 · 2019 · 5 observations
Latest: Form 483, Nov 22, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-22 | 483 Form 483 | Pomona, California | 5 | $99 |
Investigators on these documents
FEI number 1000220911 · most recent document Nov 22, 2019
About Plasdent Corporation
How many FDA Form 483s has Plasdent Corporation received?
FDA Intel has 1 Form 483 on file for Plasdent Corporation; the most recent is dated Nov 22, 2019.
When was Plasdent Corporation last inspected by FDA?
The most recent FDA inspection document on file for Plasdent Corporation is a Form 483 dated Nov 22, 2019, for the site in Pomona, California.
What did FDA cite at Plasdent Corporation?
The regulations cited most in the observations on file for Plasdent Corporation are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.120 (Device labeling), 1 time.