# FDA 483 - Ion Labs Inc. - May 12, 2016

Source: https://www.keypedia.com/records/483/ion-labs-inc/6122ec3d-9a7b-4cd9-9f0b-4a940aa7f965

> FDA 483 for Ion Labs Inc. on May 12, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ion Labs Inc.
- Inspection Date: 2016-05-12
- 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 failing to follow its own written procedures for holding and distributing operations. During an inspection, work-in-process product was observed in an undesignated warehouse location. Furthermore, there was no documentation for the observed product, indicating a lapse in procedural adherence and record-keeping.

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## Related Officers

- [Rodney W Lenger](https://www.keypedia.com/people/rodney-w-lenger/a5402999-2eb2-45cf-9448-38e5ac076f09)
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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