# FDA 483 - Chae Organics LLC - March 14, 2025

Source: https://www.globalkeysolutions.net/records/483/chae-organics-llc/b3bac52d-9069-4891-8c74-a21d627211ad

> FDA 483 for Chae Organics LLC on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chae Organics LLC
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Chae Organics LLC, a manufacturer in Walsenburg, CO, was cited for significant deficiencies in its quality control and stability testing practices for OTC drug products. The firm failed to establish appropriate expiration dates based on reliable stability data and lacked adequate preservative efficacy testing. Additionally, the company did not conduct annual product reviews as required.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

Company: https://www.globalkeysolutions.net/companies/chae-organics-llc/2ef288dd-47c1-4ad5-a3be-31e68fdee72c

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