FDA 483 - Isopure Corp. - September 23, 2019

Isopure Corp in Louisville, KY, was inspected by the FDA from September 17-23, 2019, revealing two significant issues. The firm failed to adequately document complaint investigations, specifically regarding patient risk, and did not timely report a device correction to the FDA within the required 10-day period. These observations indicate deficiencies in the firm's quality system and regulatory compliance.