FDA 483 - Organic India USA, LLC - December 11, 2018

Organic India USA, LLC, an own label distributor of dietary supplements in Boulder, CO, was cited for significant deficiencies during an FDA inspection. The firm failed to investigate numerous product complaints, including serious adverse events, for possible product specification failures. Additionally, the inspection revealed inadequate quality control operations, specifically regarding the documentation of material review, disposition of returned products, and review of Certificates of Analysis.