# FDA 483 - World Gen, LLC - August 07, 2025

Source: https://www.globalkeysolutions.net/records/483/world-gen-llc/867cd559-28cf-42de-b470-0ec1ef6c7673

> FDA 483 for World Gen, LLC on August 07, 2025. Product: veterinary. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: World Gen, LLC
- Inspection Date: 2025-08-07
- Product Type: veterinary
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of World Gen, LLC, a veterinary drug manufacturer in Hamilton, New York, revealed significant deficiencies across its manufacturing and quality control operations. Observations included failures in preventing cross-contamination, ensuring data accuracy for computer systems, validating equipment cleaning, and thoroughly investigating deviations. The firm also exhibited inadequate quality unit oversight, poor facility sanitation, and insufficient control over changes and training.

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.globalkeysolutions.net/companies/world-gen-llc/0044df5e-bc2f-4153-9115-a37f6dfc2f35

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961