> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Centurion Medical Products Kit Issues
- URL: https://www.fdaweb.com/centurion-medical-products-kit-issues/
- Published: 2020-07-21T12:00:00.000Z
- Updated: 2026-09-14T16:22:00.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5147237

FDA says Centurion Medical Products, Williamston, MI, manufactures and distributes sterile convenience kits that have not been approved or cleared by FDA. A just-released 6/11 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centurion-medical-products-corporation-598837-06112020?ref=fdaweb.com) says the agency’s 8/5-8/20/19 and 11/21-11/1/19 inspections at two Centurion sites determined that the kits contain two or more medical devices and at least one drug co-packaged together. Generally, the kits are intended for use during a variety of vascular and other procedures, FDA says.

Specific violations noted in the letter are: 

- failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
- failing to establish and maintain procedures for implementing corrective and preventive actions; and
- failing to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements.

The company was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of each corrective action and a timetable for completing the steps. FDA also offered to meet with Centurion to discuss the violations and any planned corrective actions.