# FDA 483 - Iowa Adaptive Technologies Inc. - July 11, 2019

Source: https://www.keypedia.com/records/483/iowa-adaptive-technologies-inc/31a44aee-b2ea-44cc-a8da-fa3c75efdb5a

> FDA 483 for Iowa Adaptive Technologies Inc. on July 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Iowa Adaptive Technologies Inc.
- Inspection Date: 2019-07-11
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Iowa Adaptive Technologies Inc. in Coralville, IA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm lacked written procedures for Medical Device Reporting (MDR) and had an inadequately defined complaint handling procedure. These issues indicate a failure to establish and follow proper controls for adverse event reporting and complaint management.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/iowa-adaptive-technologies-inc/e7b5765f-fa7d-457f-b7e8-bdb99c525c8c

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d