483
Vega Technologies Inc.FDA 483 - Vega Technologies Inc. - November 10, 2023
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An FDA inspection of Vega Technologies Inc., a medical device manufacturer in Dongguan, China, revealed significant deficiencies in its quality system. Observations included inadequate procedures for design validation, complaint handling, process controls, and device history records for their Medical Suction Equipment. The firm also lacked developed written Medical Device Reporting (MDR) procedures.
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ID · 4be36b3e-d5f0-46f2-8b8b-95e0e6bca179