# FDA 483 - Faunus Herbs Inc. - February 17, 2022

Source: https://www.keypedia.com/records/483/faunus-herbs-inc/f8310628-506c-411e-90a4-fcce2de58c8b

> FDA 483 for Faunus Herbs Inc. on February 17, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Faunus Herbs Inc.
- Inspection Date: 2022-02-17
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: Faunus Herbs Inc. in Sunderland, Canada, was inspected by the FDA from February 14-17, 2022, revealing significant deficiencies in their manufacturing processes. The inspection found that the firm failed to record critical factors for their herbal extract, lacked adequate documentation for dietary supplement specifications, and did not maintain written master manufacturing records for their dietary supplements. These issues indicate a lack of control over critical manufacturing parameters and documentation, which could impact product quality and consistency.

## Related Officers

- [investigator](https://www.keypedia.com/people/richard-g-fochesato/0d802787-3bc0-43bc-a1dc-90dee648290b)

Company: https://www.keypedia.com/companies/faunus-herbs-inc/b77d1619-3caa-420b-afa3-074e27c2abf3

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1