# FDA 483 - Ion Labs Inc. - June 03, 2011

Source: https://www.keypedia.com/records/483/ion-labs-inc/df7cd3b8-58fb-4dcf-acf0-db9b221c5f63

> FDA 483 for Ion Labs Inc. on June 03, 2011. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ion Labs Inc.
- Inspection Date: 2011-06-03
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ion Labs Inc. in Clearwater, FL, a dietary supplement manufacturer, was cited for significant quality control and documentation deficiencies. The firm failed to establish product and component specifications, lacked data to support label claims and expiration dates, and distributed reprocessed and out-of-specification products without proper approval or rejection. Additionally, batch production records were incomplete, missing critical manufacturing details and personnel initials.

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## Related Officers

- [investigator](https://www.keypedia.com/people/samantha-j-pinizzotto/296e8763-39e9-4b6d-9b89-661322d5a53c)
- [Approval Manager](https://www.keypedia.com/people/michael-h-tollon/5e30e7e1-5727-4169-8faf-e5d5783ac781)

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