483
Vee international incFDA 483 - Vee international inc - July 15, 2022
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An FDA inspection of Vee international inc in Garden City, NY, an importer of penile erection rigidity devices, revealed significant deficiencies in their quality system. The firm failed to perform adequate risk analysis and document design input requirements for their Class II medical devices. Additionally, there was no agreement with foreign suppliers to notify the firm of product or service changes.
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ID · 8c4862b0-ab45-434c-bfd1-8bcba6f4b0e4