# FDA 483 - Kabana Skin Care - February 20, 2025

Source: https://www.keypedia.com/records/483/kabana-skin-care/8c65dbef-5b4d-4164-b259-53c4a724d349

> FDA 483 for Kabana Skin Care on February 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kabana Skin Care
- Inspection Date: 2025-02-20
- Product Type: drugs
- Office Name: Denver District Office
- Summary: KABANA SKIN CARE, an OTC manufacturer in Louisville, CO, was cited with seven observations during an FDA inspection. The firm demonstrated a severe lack of fundamental quality control systems, including the absence of a quality control unit, inadequate written procedures for manufacturing and testing, and a failure to validate processes and equipment. These deficiencies indicate significant non-compliance with cGMP regulations, impacting product identity, strength, quality, and purity.

## Related Documents

- [WARNING_LETTER - 2025-03-18](https://www.keypedia.com/records/warning_letter/kabana-skin-care/96fbfe21-2b4b-477c-b54c-ed5f2ed8227e)
- [WARNING_LETTER - 2025-02-20](https://www.keypedia.com/records/warning_letter/kabana-skin-care/723b9d2e-904f-4ac1-ac22-cfc1bec99ee4)

## Related Officers

- [Dogbeda F. Mackenzie](https://www.keypedia.com/people/dogbeda-f-mackenzie/c522e2cb-bf53-48f3-b88a-20b7aa0238d6)

Company: https://www.keypedia.com/companies/kabana-skin-care/2cb177d5-8def-4766-979c-3e0f4ead40ea

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