# FDA 483 - Ion Labs Inc. - December 06, 2022

Source: https://www.keypedia.com/records/483/ion-labs-inc/c92d11ca-82db-4654-8c33-7eec08d04931

> FDA 483 for Ion Labs Inc. on December 06, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ion Labs Inc.
- Inspection Date: 2022-12-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ion Labs Inc., a dietary supplement manufacturer in Largo, FL, was cited for significant quality control deficiencies. The inspection revealed failures in reviewing and approving documentation for product specifications, leading to the release of out-of-specification products due to unreliable analytical test results and calculation errors. Additionally, the firm lacked established sampling plans for obtaining representative samples of finished dietary supplement batches.

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- [483 - 2023-04-28](https://www.keypedia.com/records/483/ion-labs-inc/6584eb04-ab38-4610-a647-91f4a1a5efa3)

## Related Officers

- [Aaron J. Fox](https://www.keypedia.com/people/aaron-j-fox/0a230544-8f5a-4979-afc0-736bc68f3e03)
- [Karl Hezel](https://www.keypedia.com/people/karl-hezel/4f660e27-c16c-4d62-9161-273bd55852d8)
- [Miguel A. Martinez](https://www.keypedia.com/people/miguel-a-martinez/62e722b2-30bd-4671-9db9-8f089093e5a5)

Company: https://www.keypedia.com/companies/ion-labs-inc/2b89e113-4ab2-48d1-a46e-039fd92262df

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6