# FDA 483 - GENIAL DAY INC - August 03, 2021

Source: https://www.keypedia.com/records/483/genial-day-inc/bfd1deb0-b9d1-44b2-86d0-bab596592d43

> FDA 483 for GENIAL DAY INC on August 03, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GENIAL DAY INC
- Inspection Date: 2021-08-03
- Product Type: device
- Office Name: Chicago District Office
- Summary: GENIAL DAY INC, an initial importer/distributor and repackager in Orland Park, IL, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, specifically the complete absence of established procedures for complaint handling, medical device reporting, general quality system operations, acceptance activities, and corrective and preventive actions. These findings indicate a fundamental lack of control over critical aspects of medical device quality and regulatory compliance.

## Related Officers

- [Natasha R. Johnson](https://www.keypedia.com/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

Company: https://www.keypedia.com/companies/genial-day-inc/324f52ae-13a0-464d-b336-6c45bf8c1c17

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669