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

Source: https://www.globalkeysolutions.net/records/483/organic-india-usa-llc/abe1bc2c-17e5-4ba3-a1f4-055b4490d41d

> FDA 483 for Organic India USA, LLC on December 11, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Organic India USA, LLC
- Inspection Date: 2018-12-11
- Product Type: other
- Office Name: Denver District Office
- Summary: 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.

## Related Officers

- [Lavender M Huskey](https://www.globalkeysolutions.net/people/lavender-m-huskey/9ad3f3d7-4f25-492a-b10a-ede8289e4797)

Company: https://www.globalkeysolutions.net/companies/organic-india-usa-llc/cd26873a-072f-45fa-9e3c-c96a41f0742b

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face