# FDA 483 - Ig Holdings Llc - May 08, 2025

Source: https://www.keypedia.com/records/483/ig-holdings-llc/7ee9ee4c-20df-414c-adf2-b757a2f97371

> FDA 483 for Ig Holdings Llc on May 08, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ig Holdings Llc
- Inspection Date: 2025-05-08
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: Ig Holdings Llc in Ettrick, WI, was inspected by the FDA, revealing a significant issue with process validation. The firm failed to properly validate a band sealer used for product pouches, indicating a lack of documented monitoring and control methods for a critical manufacturing process. This suggests potential risks to product quality and consistency.

## Related Officers

- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/ig-holdings-llc/72d022e2-7dab-405e-9267-8cd5d635fd2c

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