Turbo Wheelchair Co. Inc.
Form 483 issued May 2, 2017 · Louisville, Kentucky
- Inspection
- Apr 12 – May 2, 2017
- Investigator
- Shannon A. Gregory
- Observations
- 10
- Pages
- 5
- FEI number
- 3004149089
In short: On May 2, 2017, FDA issued a Form 483 with 10 observations to Turbo Wheelchair Co. Inc. in Louisville, Kentucky (FEI 3004149089) after an inspection that ran Apr 12 – May 2, 2017. The investigator was Shannon A. Gregory. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Quality system procedures and instructions…
- 02
A device master record has…
- 03
A device history record has…
- 04
Procedures for acceptance activities…
This inspection in context
Shannon A. Gregory
5 documents · 2015–2022
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Kentucky.
The firmTurbo Wheelchair Co. Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Turbo Wheelchair Co. Inc.?
FDA listed 10 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The opening words of each observation are shown on this page.
Who inspected Turbo Wheelchair Co. Inc.?
Shannon A. Gregory is named on this Form 483, for the inspection of Apr 12 – May 2, 2017. Each investigator has a profile showing what they cite most.
When was Turbo Wheelchair Co. Inc. inspected by FDA?
The inspection ran Apr 12 – May 2, 2017, and the Form 483 is dated May 2, 2017.
How do I get the full Form 483 for Turbo Wheelchair Co. 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.