# FDA 483 - Primus Corporation dba Trinity Biotech - February 06, 2020

Source: https://www.keypedia.com/records/483/primus-corporation-dba-trinity-biotech/21d9a69d-3de3-41ac-b392-5d1dd1719520

> FDA 483 for Primus Corporation dba Trinity Biotech on February 06, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Primus Corporation dba Trinity Biotech
- Inspection Date: 2020-02-06
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Primus Corporation, a medical device manufacturer in Kansas City, MO, was cited for significant deficiencies in its quality system. Observations included a lack of records for non-reportable correction and removal actions, an inadequate risk analysis procedure that was not properly implemented, and an incomplete design history file lacking required verifications and validations. These issues indicate systemic problems with the firm's quality management and design control processes.

## Related Documents

- [WARNING_LETTER - 2020-02-06](https://www.keypedia.com/records/warning_letter/primus-corporation-dba-trinity-biotech/20468464-6d2d-4c66-a80d-b02394382ec7)

## Related Officers

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

Company: https://www.keypedia.com/companies/primus-corporation-dba-trinity-biotech/df325fd3-9d48-441b-a9f5-54b8401243c5

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