# FDA 483 - Therametric Technologies, Inc. - September 11, 2014

Source: https://www.globalkeysolutions.net/records/483/therametric-technologies-inc/f774ec19-9524-458a-a039-309ed996be4d

> FDA 483 for Therametric Technologies, Inc. on September 11, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Therametric Technologies, Inc.
- Inspection Date: 2014-09-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of THERAMETRIC TECHNOLOGIES, INC. in Noblesville, IN, revealed widespread deficiencies in their quality system for the FluoreCam caries detection device. The firm failed to establish or adequately implement procedures for critical areas including corrective and preventive actions, complaint handling, design controls, process validation, and overall quality management. These systemic issues indicate a significant lack of documented and controlled processes for medical device manufacturing.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/joseph-r-strelnik/1fb7d50e-abf2-45ef-85a8-71c61b33e42d)

Company: https://www.globalkeysolutions.net/companies/therametric-technologies-inc/42213ce4-e5ee-44e3-a03e-9d35c1c9c4ee

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0