# FDA 483 - Kimball Electronics - Indianapolis - February 24, 2022

Source: https://www.keypedia.com/records/483/kimball-electronics-indianapolis/ef46a1d7-bcfb-48dd-9b7f-c500dc2ec354

> FDA 483 for Kimball Electronics - Indianapolis on February 24, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kimball Electronics - Indianapolis
- Inspection Date: 2022-02-24
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Kimball Electronics - Indianapolis revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design verification, corrective and preventive actions, and in-process product control. These issues could lead to critical device malfunctions, including inaccurate drug delivery or device failure, posing a risk of injury or death to users.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/joseph-r-strelnik/1fb7d50e-abf2-45ef-85a8-71c61b33e42d)
- [Robert M. Barbosa](https://www.keypedia.com/people/robert-m-barbosa/41672e72-4ddd-4093-8069-6e49f0c8a873)

Company: https://www.keypedia.com/companies/kimball-electronics-indianapolis/f00e5d7c-03e6-439d-a0d8-f39676034618

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0