APEX DENTAL SLEEP LAB LLC
Form 483 issued February 22, 2024 · La Mesa, California
- Inspection
- Feb 13 – Feb 22, 2024
- Investigator
- Juanj Wu
- Observations
- 4
- Pages
- 3
- FEI number
- 3012716038
In short: On February 22, 2024, FDA issued a Form 483 with 4 observations to APEX DENTAL SLEEP LAB LLC in La Mesa, California (FEI 3012716038) after an inspection that ran Feb 13 – Feb 22, 2024. The investigator was Juanj Wu. Most observations concern cAPA.
At a glance
3 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
- 02
Procedures for rework of nonconforming product…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
The medical device(s) label did not have a unique device…
This inspection in context
Juanj Wu
2 documents · 2024
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in California.
The firmAPEX DENTAL SLEEP LAB LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at APEX DENTAL SLEEP LAB LLC?
FDA listed 4 observations on this Form 483, mostly about cAPA. The opening words of each observation are shown on this page.
Who inspected APEX DENTAL SLEEP LAB LLC?
Juanj Wu is named on this Form 483, for the inspection of Feb 13 – Feb 22, 2024. Each investigator has a profile showing what they cite most.
When was APEX DENTAL SLEEP LAB LLC inspected by FDA?
The inspection ran Feb 13 – Feb 22, 2024, and the Form 483 is dated February 22, 2024.
How do I get the full Form 483 for APEX DENTAL SLEEP LAB LLC?
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.