Organics Corporation of America DBA Ambix LaboratoriesAugust 22, 2014

FDA 483 - Organics Corporation of America DBA Ambix Laboratories - August 22, 2014

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Record Details

An FDA inspection of Organics Corporation of America DBA Ambix Laboratories, a dietary supplements manufacturer in Totowa, NJ, revealed significant deviations. Observations included inadequate quality control operations with unreviewed laboratory test results, incomplete batch production records lacking required verifications, and manufacturing operations that posed a contamination risk.

Company: Organics Corporation of America DBA Ambix Laboratories
Inspection Date: August 22, 2014
Product Type: Other
Office: New Jersey District Office
Person: Helen Verdel (Director of Clinical Training)

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ID · ce2de9df-034b-4e6d-a2e6-32218875cc75