Ion Labs Inc.May 12, 2016

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

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Record Details

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.

Company: Ion Labs Inc.
Inspection Date: May 12, 2016
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
People: Tracy L. Reed
Rodney W Lenger
Kari D Hazel

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ID · 6122ec3d-9a7b-4cd9-9f0b-4a940aa7f965