National Advanced Endoscopy Devices Inc
Form 483 issued September 3, 2020 · Canoga Park, California
- Inspection
- Aug 26 – Sep 3, 2020
- Investigator
- Juanita Banuelos
- Observations
- 1
- Pages
- 3
- FEI number
- 3000204191
In short: On September 3, 2020, FDA issued a Form 483 with 1 observation to National Advanced Endoscopy Devices Inc in Canoga Park, California (FEI 3000204191) after an inspection that ran Aug 26 – Sep 3, 2020. The investigator was Juanita Banuelos. Most observations concern records & documents; the most-cited regulation is 21 CFR 820.184 (device history record).
At a glance
1 of 1 observations on this 483 concern records & documents.
Most cited: 21 CFR 820.184 (1×)
What FDA observed
Preview: the opening words of each observation- 01
A device history record has…
This inspection in context
Juanita Banuelos
1 document · 2020
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in California.
The firmNational Advanced Endoscopy Devices Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at National Advanced Endoscopy Devices Inc?
FDA listed 1 observation on this Form 483, mostly about records & documents. The most-cited regulation is 21 CFR 820.184 (device history record). The opening words of each observation are shown on this page.
Who inspected National Advanced Endoscopy Devices Inc?
Juanita Banuelos is named on this Form 483, for the inspection of Aug 26 – Sep 3, 2020. Each investigator has a profile showing what they cite most.
When was National Advanced Endoscopy Devices Inc inspected by FDA?
The inspection ran Aug 26 – Sep 3, 2020, and the Form 483 is dated September 3, 2020.
How do I get the full Form 483 for National Advanced Endoscopy Devices Inc?
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.