483
HPSRx Enterprise Inc.HPSRx Enterprise Inc. – FDA 483, May 7, 2025
Record Details
An FDA inspection of HPSRX Enterprise Inc., an initial importer in Salem, VA, revealed a significant deficiency in their quality system. The firm failed to adequately establish and implement procedures for controlling nonconforming product. Specifically, issues were noted with the documentation of problems with incoming finished devices and the inspection process for these devices.
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ID · 8f6e7da3-34a7-4369-882a-e88626850fc1
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