# FDA 483 - Vireo Resources, LLC - August 11, 2022

Source: https://www.keypedia.com/records/483/vireo-resources-llc/071f8efe-dada-4877-ae24-e15c23fdd6e0

> FDA 483 for Vireo Resources, LLC on August 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vireo Resources, LLC
- Inspection Date: 2022-08-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Vireo Resources LLC, a manufacturer in Plattsmouth, NE, was cited for significant deficiencies in its manufacturing and quality control processes for both drug products (pH-D Feminine Health Suppositories) and dietary supplements. Observations included failures in finished product and raw material testing, lack of stability and process validation programs, inadequate control records, and insufficient annual product reviews. These issues indicate a systemic lack of adherence to good manufacturing practices.

## Related Officers

- [investigator](https://www.keypedia.com/people/cody-j-alley/011a38ca-0f79-40f2-b5f5-f652f2dd07d4)
- [Torrey M. Ward](https://www.keypedia.com/people/torrey-m-ward/e3021951-811e-45a0-a029-69c7cc862fcf)

Company: https://www.keypedia.com/companies/vireo-resources-llc/96ca02f9-0e6e-4d04-95b1-733e98974cc4

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8