The See Clear Company
Form 483 issued November 22, 2019 · Peachtree Corners, Georgia
- Inspection
- Oct 23 – Nov 22, 2019
- Investigators
- Dawn M. Braswell· Sayeeda Hdabe
- Observations
- 6
- Pages
- 6
- FEI number
- 3009384112
In short: On November 22, 2019, FDA issued a Form 483 with 6 observations to The See Clear Company in Peachtree Corners, Georgia (FEI 3009384112) after an inspection that ran Oct 23 – Nov 22, 2019. The investigators were Dawn M. Braswell and Sayeeda Hdabe. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The design history file was not established and does not demonstrate that the design was developed…
- 02
The type and extent of control to be exercised over the product, services, suppliers, contractors and…
- 03
Collective and preventive action activities and/or results have…
- 0421 CFR 820.198(a)21 CFR 803
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Dawn M. Braswell
4 documents · 2019–2023
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Georgia.
The firmThe See Clear Company history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(j)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The See Clear Company?
FDA listed 6 observations on this Form 483, mostly about cAPA, management controls and design controls. The opening words of each observation are shown on this page.
Who inspected The See Clear Company?
Dawn M. Braswell and Sayeeda Hdabe are named on this Form 483, for the inspection of Oct 23 – Nov 22, 2019. Each investigator has a profile showing what they cite most.
When was The See Clear Company inspected by FDA?
The inspection ran Oct 23 – Nov 22, 2019, and the Form 483 is dated November 22, 2019.
How do I get the full Form 483 for The See Clear Company?
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.