Kimball Electronics Indianapolis, Inc.
Form 483 issued February 24, 2022 · Indianapolis, Indiana
- Inspection
- Feb 8 – Feb 24, 2022
- Investigators
- Joseph R. Strelnik· Robert M. Barbosa
- Observations
- 3
- Pages
- 6
- FEI number
- 3004598644
In short: On February 24, 2022, FDA issued a Form 483 with 3 observations to Kimball Electronics Indianapolis, Inc. in Indianapolis, Indiana (FEI 3004598644) after an inspection that ran Feb 8 – Feb 24, 2022. The investigators were Joseph R. Strelnik and Robert M. Barbosa. Most observations concern design controls and cAPA.
At a glance
Design controls and capa account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design verification have…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures for the control of in-process product have…
This inspection in context
Joseph R. Strelnik
13 documents · 2011–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmKimball Electronics Indianapolis, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kimball Electronics Indianapolis, Inc.?
FDA listed 3 observations on this Form 483, mostly about design controls, cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Kimball Electronics Indianapolis, Inc.?
Joseph R. Strelnik and Robert M. Barbosa are named on this Form 483, for the inspection of Feb 8 – Feb 24, 2022. Each investigator has a profile showing what they cite most.
When was Kimball Electronics Indianapolis, Inc. inspected by FDA?
The inspection ran Feb 8 – Feb 24, 2022, and the Form 483 is dated February 24, 2022.
How do I get the full Form 483 for Kimball Electronics Indianapolis, 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.