Repro-Med Systems ’483 Released

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.