# FDA 483 - Isopure Corp. - September 23, 2019

Source: https://www.globalkeysolutions.net/records/483/isopure-corp/f646d1ed-3ee6-405a-bee0-5290d408c8b7

> FDA 483 for Isopure Corp. on September 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isopure Corp.
- Inspection Date: 2019-09-23
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: 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.

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.globalkeysolutions.net/companies/isopure-corp/3d9ba5d6-4c45-4455-a957-6e514aec2334

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22