# FDA 483 - Osmosis, LLC - January 13, 2023

Source: https://www.globalkeysolutions.net/records/483/osmosis-llc/5b222b26-5766-4879-b1d8-a550cec7a1d2

> FDA 483 for Osmosis, LLC on January 13, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Osmosis, LLC
- Inspection Date: 2023-01-13
- Product Type: other
- Office Name: Denver District Office
- Summary: An FDA inspection of Osmozis, LLC, a dietary supplement manufacturer in Evergreen, CO, from January 5-13, 2023, revealed numerous significant deficiencies across its operations. The firm failed to establish and follow written procedures for critical areas including quality control, component and finished product specifications, supplier qualification, sanitation, complaint handling, master manufacturing records, batch production records, and handling of returned products. These widespread issues indicate a severe lack of control over manufacturing processes and product quality.

## Related Documents

- [WARNING_LETTER - 2023-01-13](https://www.globalkeysolutions.net/records/warning_letter/osmosis-llc/ba8e52c6-ba45-4c10-99bc-dedcd50d4deb)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/osmosis-llc/33022cae-591c-4794-8472-5d2464c98c50

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