# FDA 483 - Americanna Wellness Inc - October 28, 2024

Source: https://www.keypedia.com/records/483/americanna-wellness-inc/767813bf-e0a5-41cc-b2b1-fef9726fe2cd

> FDA 483 for Americanna Wellness Inc on October 28, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Americanna Wellness Inc
- Inspection Date: 2024-10-28
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: Americanna Wellness Incorporated in Bellingham, WA, a manufacturer of finished drug products, was inspected by the FDA. The inspection revealed significant deficiencies across its quality control unit, component testing, production and process controls, equipment qualification, and master production and control records. These issues indicate a lack of fundamental procedures and documentation necessary to ensure drug product identity, strength, purity, and quality.

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/aranjeet-singh/7359f43e-0e36-4cdd-a77d-3371d8b44b99)
- [issuing_officer](https://www.keypedia.com/people/michael-araneta/c94c95f4-2cda-43f5-a02a-2b5d82fe2c7d)

Company: https://www.keypedia.com/companies/americanna-wellness-inc/dcbfc253-7d28-47e2-bfe9-e03ada2d5b7e

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913