483
Repro-Med Systems, Inc.Repro-Med Systems, Inc. – FDA 483, Oct 19, 2017
Record Details
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.
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ID · 75802b90-2603-4d03-b633-aa4ea5a69b03
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