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# Multiple Violations in Repro-Med Systems Inspection
- URL: https://www.fdaweb.com/multiple-violations-in-repro-med-systems-inspection/
- Published: 2016-03-08T12:00:00.000Z
- Updated: 2026-09-15T02:41:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135005

> A 6/3-6/23/15 FDA inspection at Repro-Med Systems, Chester, NY found multiple violations in the firm’s work as a specification developer and manufacturer of infusion pumps and intravascular administration sets, according to a 2/26 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm488301.htm?ref=fdaweb.com) from the agency’s New York District Office. Specific violations noted on an FDA-483 included:  
> the company’s Class 3 infusion pumps do not have an approved PMA or IND in effect; the company did not notify FDA of its intent to introduce the infusion pumps into commercial distribution; the Freedom 60 Syringe Infusion Pump that has a 510(k) clearance was modified in a manner that could significantly affect safety and effectiveness; the firm is promoting the Freedom 60 for indications that would constitute a major change or modification to the device’s intended use, for which it lacks clearance or approval; the RMS High-Flo subcutaneous safety needle set is a Class 3 device that does not have an approved application for PMA or IND in effect; the company did not notify FDA of its intent to introduce the needle set into commercial distribution; the company is promoting the needle set for an indication outside the cleared intended use; failing to complete design verification activities to confirm that the design output meets the design input requirements; failing to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation; failing to establish procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained; failing to establish and maintain procedures for rework, including retesting and revaluation of nonconforming product after rework, to ensure that the product meets the current approved specifications; failing to establish and maintain procedures for implementing corrective and preventive action; failing to establish and maintain procedures for acceptance activities; and failing to furnish material or information required under Medical Device Reporting regulations.  
>  
> The company was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.