Custom Smiles I no
FDA inspection history in Kannapolis, North Carolina, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Kannapolis, North Carolina.
Cited most
Across all Custom Smiles I no observations on file
- 21 CFR 820.20(a)Management responsibility3
- 21 CFR 820.120(b)Device labeling2
- 21 CFR 820.200(b)Servicing2
- 21 CFR 820.184Device history record1
- 21 CFR 820.198(b)Complaint files1
The complete Custom Smiles I no file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Kannapolis, North Carolina
One Form 483 · 2022 · 13 observations
Latest: Form 483, Mar 18, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-18 | 483 Form 483 | Kannapolis, North Carolina | 13 | $99 |
Investigators on these documents
FEI number 3014945982 · most recent document Mar 18, 2022
About Custom Smiles I no
How many FDA Form 483s has Custom Smiles I no received?
FDA Intel has 1 Form 483 on file for Custom Smiles I no; the most recent is dated Mar 18, 2022.
When was Custom Smiles I no last inspected by FDA?
The most recent FDA inspection document on file for Custom Smiles I no is a Form 483 dated Mar 18, 2022, for the site in Kannapolis, North Carolina.
What did FDA cite at Custom Smiles I no?
The regulations cited most in the observations on file for Custom Smiles I no are 21 CFR 820.20(a) (Management responsibility), 3 times; 21 CFR 820.120(b) (Device labeling), 2 times; 21 CFR 820.200(b) (Servicing), 2 times.