# FDA 483 - Titronics Research & Development Co. - July 09, 2019

Source: https://www.globalkeysolutions.net/records/483/titronics-research-development-co/12f3cb54-531d-4b90-bfb1-a57a3f10ea69

> FDA 483 for Titronics Research & Development Co. on July 09, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Titronics Research & Development Co.
- Inspection Date: 2019-07-09
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Titronics Research & Development Co. in Tiffin, IA, received a Form FDA 483 following an inspection that revealed significant deficiencies in their quality system. Observations included inadequate implementation of procedures for nonconforming product control, insufficient details in calibration procedures, and a failure to adequately establish and implement document control. Additionally, the firm was cited for not adequately maintaining device history records and for an undefined DHR retention procedure.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.globalkeysolutions.net/companies/titronics-research-development-co/cb427513-a4b3-446a-8433-8053761a4f21

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d