CPAPNEA Medical Supply
Form 483 issued October 7, 2020 · Phoenix, Arizona
- Inspection
- Oct 5 – Oct 7, 2020
- Investigator
- Eric C. Fox
- Observations
- 3
- Pages
- 4
- FEI number
- 3015339284
In short: On October 7, 2020, FDA issued a Form 483 with 3 observations to CPAPNEA Medical Supply in Phoenix, Arizona (FEI 3015339284) after an inspection that ran Oct 5 – Oct 7, 2020. The investigator was Eric C. Fox. Most observations concern cAPA and records & documents.
At a glance
CAPA and records & documents account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
A device master record…
- 03
Procedures for design control…
This inspection in context
Eric C. Fox
3 documents · 2020–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Arizona.
The firmCPAPNEA Medical Supply history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CPAPNEA Medical Supply?
FDA listed 3 observations on this Form 483, mostly about cAPA, records & documents and design controls. The opening words of each observation are shown on this page.
Who inspected CPAPNEA Medical Supply?
Eric C. Fox is named on this Form 483, for the inspection of Oct 5 – Oct 7, 2020. Each investigator has a profile showing what they cite most.
When was CPAPNEA Medical Supply inspected by FDA?
The inspection ran Oct 5 – Oct 7, 2020, and the Form 483 is dated October 7, 2020.
How do I get the full Form 483 for CPAPNEA Medical Supply?
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.