# FDA 483 - Isopure Corp. - August 15, 2024

Source: https://www.keypedia.com/records/483/isopure-corp/d5714597-9bad-439a-a748-027461b5b972

> FDA 483 for Isopure Corp. on August 15, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isopure Corp.
- Inspection Date: 2024-08-15
- Product Type: other
- Office Name: FDA District Office — Cincinnati, Ohio
- Summary: 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.

## Related Documents

- [483 - 2019-09-23](https://www.keypedia.com/records/483/isopure-corp/f646d1ed-3ee6-405a-bee0-5290d408c8b7)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/fda-district-office-cincinnati-ohio/b4972fd9-9db9-4cc6-9a4c-0146959c9d74