# FDA 483 - Ion Labs Inc. - May 07, 2013

Source: https://www.keypedia.com/records/483/ion-labs-inc/ef75e67e-0e16-4276-98d9-e0f6dce6d57c

> FDA 483 for Ion Labs Inc. on May 07, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ion Labs Inc.
- Inspection Date: 2013-05-07
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ion Labs Inc., a dietary supplement manufacturer in Clearwater, FL, was cited for multiple significant deficiencies in its quality control and manufacturing processes during an FDA inspection. The firm failed to establish and test product specifications, confirm component identity, qualify suppliers, and properly manage reprocessed batches and unanticipated manufacturing deviations. Many of these issues were repeat observations from previous inspections, indicating a systemic lack of compliance with good manufacturing practices.

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## Related Officers

- [Approval Manager](https://www.keypedia.com/people/michael-h-tollon/5e30e7e1-5727-4169-8faf-e5d5783ac781)
- [David P. King](https://www.keypedia.com/people/david-p-king/b420ffcd-5ae1-40d3-a72a-5ac41bdba0eb)

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