# FDA 483 - American Thermal Instruments Inc - March 14, 2022

Source: https://www.globalkeysolutions.net/records/483/american-thermal-instruments-inc/219eb3c8-f07f-4d14-861b-68c72f7aac23

> FDA 483 for American Thermal Instruments Inc on March 14, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Thermal Instruments Inc
- Inspection Date: 2022-03-14
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: American Thermal Instruments Inc. in Dayton, OH, a manufacturer of forehead thermometers, was cited for multiple quality system deficiencies during an FDA inspection. The observations primarily concern inadequate process validation, design input procedures, production process monitoring, device history records, purchasing controls, and complaint handling, indicating significant issues in ensuring device quality and regulatory compliance.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/american-thermal-instruments-inc/fc83d7d9-be98-4084-8bfb-be7dcc903bd9

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