483
Netech Corp.Netech Corp. – FDA 483, Apr 14, 2023
Record Details
Netech Corp., a medical device manufacturer in Farmingdale, NY, was cited for three observations during an FDA inspection. The firm failed to adequately document equipment calibrations and maintain complete device history records. Additionally, Netech Corp. lacked proper electronic Medical Device Reporting (eMDR) procedures and an Electronic Submissions Gateway (ESG) account.
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ID · 9fa8eb26-afda-44eb-8875-7f3871f7b615
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