483
Personal Medical Corp.Personal Medical Corp. – FDA 483, Jul 19, 2019
Record Details
An FDA inspection of Personal Medical Corp. in Redmond, WA, a manufacturer of Class I and Class II medical devices, revealed two significant observations. The firm failed to maintain adequate device history records, specifically lacking primary identification labels and unique device identifiers for manufactured lots. Additionally, the company did not have a documented quality policy established by executive management.
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ID · fe1c2430-f420-4cea-9137-97f0633a956d
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