Chief Power Chair, LLC
Form 483 issued July 30, 2024 · Tucson, Arizona
- Inspection
- Jul 10 – Jul 30, 2024
- Investigator
- Scott D. Stevens
- Observations
- 3
- Pages
- 7
- FEI number
- 3004620958
In short: On July 30, 2024, FDA issued a Form 483 with 3 observations to Chief Power Chair, LLC in Tucson, Arizona (FEI 3004620958) after an inspection that ran Jul 10 – Jul 30, 2024. The investigator was Scott D. Stevens. Most observations concern records & documents and management controls; the most-cited regulation is 21 CFR 820.181 (device master record).
At a glance
Records & documents and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.181 (1×) · 820.22 (1×)
What FDA observed
Preview: the opening words of each observation- 01
A device master record has…
- 02
Procedures for quality audits have…
This inspection in context
Scott D. Stevens
3 documents · 2024–2026
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Arizona.
The firmChief Power Chair, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.181
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chief Power Chair, LLC?
FDA listed 3 observations on this Form 483, mostly about records & documents and management controls. The most-cited regulation is 21 CFR 820.181 (device master record). The opening words of each observation are shown on this page.
Who inspected Chief Power Chair, LLC?
Scott D. Stevens is named on this Form 483, for the inspection of Jul 10 – Jul 30, 2024. Each investigator has a profile showing what they cite most.
When was Chief Power Chair, LLC inspected by FDA?
The inspection ran Jul 10 – Jul 30, 2024, and the Form 483 is dated July 30, 2024.
How do I get the full Form 483 for Chief Power Chair, 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.