FDA 483 - Repro-Med Systems, Inc. - October 19, 2017

An FDA inspection of Repro-Med Systems, Inc., a medical device manufacturer in Chester, NY, revealed two significant observations. The firm was cited for inadequate design validation studies for its HighFlo Subcutaneous Safety Needle Sets, as well as for failing to establish proper corrective and preventive action procedures. These deficiencies were highlighted by a lack of root-cause investigations for numerous product complaints.