# FDA 483 - The Hygenic Company LLC. - December 17, 2021

Source: https://www.keypedia.com/records/483/the-hygenic-company-llc/f6f9c988-a71e-4ec1-9e24-34ca933defde

> FDA 483 for The Hygenic Company LLC. on December 17, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Hygenic Company LLC.
- Inspection Date: 2021-12-17
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: The Hygenic Company LLC, a manufacturer located in Akron, OH, received a Form FDA 483 with two observations. The inspection revealed that the firm failed to adequately establish procedures for the acceptance of incoming products and did not maintain adequate records for acceptable contractors, specifically concerning equipment calibration services. These findings indicate deficiencies in the firm's quality system controls.

## Related Officers

- [investigator](https://www.keypedia.com/people/javonica-f-penn/56294265-08fc-4d1d-8a34-626fc4dad457)

Company: https://www.keypedia.com/companies/the-hygenic-company-llc/28efd539-c597-4c73-839e-9ac2ae688bed

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22