> ## 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.

# Repro-Med Working on 3 Warning Letter Items
- URL: https://www.fdaweb.com/repro-med-working-on-3-warning-letter-items/
- Published: 2016-03-09T12:00:00.000Z
- Updated: 2026-09-15T02:42:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135025

> Repro-Med says that some of the inspection observations from 6/2015 cited in a recent [Warning Letter](https://www.fdaweb.com/multiple-violations-in-repro-med-systems-inspection/) from FDA’s New York District Office had already been resolved to the agency’s satisfaction and three observations require additional clarification. Company officials say they are in the process of addressing the three issues and providing the additional documentation needed. “There were no safety concerns raised by the points made in the Warning Letter,” the statement says. “While we anticipate one item taking a bit longer to resolve,” says company chief medical officer **Fred Ma**, “the others are merely an exercise in better communicating our thorough processes and premium safety standards to FDA.”