# FDA 483 - Zarbee's Inc - June 17, 2015

Source: https://www.globalkeysolutions.net/records/483/zarbees-inc/35b26804-4dc7-4a99-96ee-298ff6883634

> FDA 483 for Zarbee's Inc on June 17, 2015. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Zarbee's Inc
- Inspection Date: 2015-06-17
- Product Type: other
- Office Name: Denver District Office
- Summary: Zarbee's, Inc., a dietary supplement own label distributor in Draper, UT, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to report serious adverse events associated with its dietary supplements to the FDA via MedWatch and did not properly investigate numerous product complaints, including those involving children requiring medical treatment. Additionally, the company did not follow its own written procedures for complaint handling and lacked documentation for the qualification of its product manufacturers.

## Related Documents

- [483 - 2015-07-09](https://www.globalkeysolutions.net/records/483/zarbees-inc/2f5b375f-1d79-453c-812d-d5e26114a8b4)
- [483 - 2017-12-11](https://www.globalkeysolutions.net/records/483/zarbees-inc/35194fb7-ee7d-4e89-8ff0-6de294e42c8a)

## Related Officers

- [James R. Montero](https://www.globalkeysolutions.net/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.globalkeysolutions.net/companies/zarbees-inc/0ca5d801-6f18-4c66-ad4d-08b113139c7e

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