# FDA 483 - Zurex PharmAgra, LLC - January 08, 2016

Source: https://www.globalkeysolutions.net/records/483/zurex-pharmagra-llc/f5cd026f-155f-42fd-ad5a-b61b78ea8062

> FDA 483 for Zurex PharmAgra, LLC on January 08, 2016. Product: veterinary. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Zurex PharmAgra, LLC
- Inspection Date: 2016-01-08
- Product Type: veterinary
- Office Name: Minneapolis District Office
- Summary: Furex PharmaGra, LLC, an animal drug manufacturer in Middleton, WI, was cited for significant deficiencies during an FDA inspection. The firm lacks an established Quality Control Unit to oversee animal drug manufacturing by its contract manufacturer. Additionally, the inspection revealed inadequate written procedures for handling, sampling, testing, and approval of components, drug product containers, and closures.

## Related Officers

- [Howard A Burmester](https://www.globalkeysolutions.net/people/howard-a-burmester/ddeb12ce-4d55-493b-a2b2-8bc9cf47f086)

Company: https://www.globalkeysolutions.net/companies/zurex-pharmagra-llc/6b65cbce-6312-44ed-81e7-7c3d7b6a72db

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d