# FDA 483 - Ion Labs Inc. - August 02, 2012

Source: https://www.globalkeysolutions.net/records/483/ion-labs-inc/a691a974-e1a3-4986-a3ae-b44932ccd3ca

> FDA 483 for Ion Labs Inc. on August 02, 2012. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ion Labs Inc.
- Inspection Date: 2012-08-02
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Ion Labs Inc., a dietary supplement manufacturer in Clearwater, FL, revealed 12 significant observations, many of which were repeat violations from a previous inspection. The firm failed to establish and follow critical quality control procedures, including product and component specifications, appropriate testing, material review for non-conformances and reprocessed products, and proper handling of customer complaints. These deficiencies indicate a systemic lack of control over the manufacturing and quality assurance processes for dietary supplements.

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## Related Officers

- [Approval Manager](https://www.globalkeysolutions.net/people/michael-h-tollon/5e30e7e1-5727-4169-8faf-e5d5783ac781)

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

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