483
TeleMed SystemsFDA 483 - TeleMed Systems - July 02, 2026
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An FDA inspection of Shent USA, Inc. in Northborough, MA, a medical device manufacturer, revealed significant deficiencies in design and development outputs. The firm failed to adequately define material specifications for its Class II Sclerotherapy Needle and its sterile barrier system packaging. These issues indicate a lack of robust design control and potential risks to product quality.
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ID · a8ca302e-0005-4580-9bca-dfd144fb110e