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# Repro-Med Systems ’483 Released
- URL: https://www.fdaweb.com/repro-med-systems-483-released/
- Published: 2017-05-23T12:00:00.000Z
- Updated: 2026-09-14T22:25:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138757

FDA has released the FDA-483 issued at the completion of an 11/29-12/16/16 agency inspection at Repro-Med Systems, Chester, NY. Inspection observations were: 

- failing to report in writing to FDA a correction or removal conducted to reduce a health risk posed by a medical device;
- failing to adequately establish procedures for design change;
- failing to adequately establish procedures for corrective and preventive action;
- failing to adequately establish procedures to control product that does not conform to specified requirements;
- failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to document rework and reevaluation activities in the device history record;
- failing to have design verification confirm that design output meets design input requirements; and
- failing to adequately establish records of acceptable suppliers.