Isopure Corp.August 15, 2024

FDA 483 - Isopure Corp. - August 15, 2024

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Record Details

Isopure Corp. in Louisville, KY, was inspected by the FDA from August 12-15, 2024. The inspection revealed that the firm's procedures for receiving, reviewing, and evaluating complaints were not adequately established. Specifically, Customer Service Report forms lacked required documentation for Medical Device Report (MDR) determination and routinely contained empty data fields.

Company: Isopure Corp.
Inspection Date: August 15, 2024
Product Type: Other
Office: FDA District Office — Cincinnati, Ohio
Person: Shannon A. Gregory

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