# FDA 483 - Bio-Thesiometer USA - January 19, 2018

Source: https://www.keypedia.com/records/483/bio-thesiometer-usa/3c37584e-e394-41ac-8a45-341c9158022b

> FDA 483 for Bio-Thesiometer USA on January 19, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Thesiometer USA
- Inspection Date: 2018-01-19
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Bio-Thesiometer USA, a medical device manufacturer in Cleveland, OH, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked established procedures for receiving, reviewing, and evaluating customer complaints, with the complaint form missing critical documentation. Additionally, the company had not developed written procedures for evaluating and submitting Medical Device Reports (MDRs).

## Related Documents

- [EIR - 2018-01-19](https://www.keypedia.com/records/eir/bio-thesiometer-usa/e86e2680-bf02-478f-8aa7-e496bbf41cde)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/bio-thesiometer-usa/cc92df30-768a-4d6c-a27e-cf5c23a3886c

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