Custom Smiles I no
Form 483 issued March 18, 2022 · Kannapolis, North Carolina
- Inspection
- Mar 14 – Mar 18, 2022
- Investigator
- Gamal A. Norton
- Observations
- 13
- Pages
- 9
- FEI number
- 3014945982
In short: On March 18, 2022, FDA issued a Form 483 with 13 observations to Custom Smiles I no in Kannapolis, North Carolina (FEI 3014945982) after an inspection that ran Mar 14 – Mar 18, 2022. The investigator was Gamal A. Norton. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
Production & process controls and management controls account for 10 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
Process validation have not…
- 02
Not all complaints have been reviewed and evaluated to determine whether…
- 03
A device history record…
- 04
The DHR does not include records of examination and release of device labeling, including date and…
This inspection in context
Gamal A. Norton
16 documents · 2003–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmCustom Smiles I no history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Smiles I no?
FDA listed 13 observations on this Form 483, mostly about production & process controls, management controls and records & documents. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Custom Smiles I no?
Gamal A. Norton is named on this Form 483, for the inspection of Mar 14 – Mar 18, 2022. Each investigator has a profile showing what they cite most.
When was Custom Smiles I no inspected by FDA?
The inspection ran Mar 14 – Mar 18, 2022, and the Form 483 is dated March 18, 2022.
How do I get the full Form 483 for Custom Smiles I no?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.