Kimball Electronics Indianapolis, Inc.
Form 483 issued June 4, 2015 · Indianapolis, Indiana
- Inspection
- May 13 – Jun 4, 2015
- Investigator
- Debara Reese
- Observations
- 4
- Pages
- 5
- FEI number
- 3004598644
In short: On June 4, 2015, FDA issued a Form 483 with 4 observations to Kimball Electronics Indianapolis, Inc. in Indianapolis, Indiana (FEI 3004598644) after an inspection that ran May 13 – Jun 4, 2015. The investigator was Debara Reese. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures have not been adequately established to control product that does not…
- 04
Schedules for the adjustment, cleaning, and other maintenance of equipment have…
This inspection in context
Debara Reese
6 documents · 2015–2023
Cites 820.75(a) (process validation) 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 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kimball Electronics Indianapolis, Inc.?
FDA listed 4 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Kimball Electronics Indianapolis, Inc.?
Debara Reese is named on this Form 483, for the inspection of May 13 – Jun 4, 2015. Each investigator has a profile showing what they cite most.
When was Kimball Electronics Indianapolis, Inc. inspected by FDA?
The inspection ran May 13 – Jun 4, 2015, and the Form 483 is dated June 4, 2015.
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.