# FDA 483 - CivaTech Oncology Inc. - June 14, 2023

Source: https://www.globalkeysolutions.net/records/483/civatech-oncology-inc/7b0c7af1-189c-4417-bf23-bdd0083548ed

> FDA 483 for CivaTech Oncology Inc. on June 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CivaTech Oncology Inc.
- Inspection Date: 2023-06-14
- Product Type: device
- Office Name: Atlanta District Office
- Summary: CivaTech Oncology Inc. in Morrisville, NC, was inspected and received a Form FDA 483 with four observations related to its CivaString sterile implantable Class II medical device. The observations highlight deficiencies in risk analysis (a repeat finding), design input documentation, device history record maintenance, and finished device acceptance procedures. These issues indicate significant concerns with the firm's quality system for medical device manufacturing.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/inga-m-warr/f27805b8-c2ba-4af5-bf5e-ff2e2f511ec1)

Company: https://www.globalkeysolutions.net/companies/civatech-oncology-inc/1a0f5137-154e-43c6-b7ff-3b0a2d799001

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7