# FDA 483 - PReye, LLC - March 19, 2026

Source: https://www.keypedia.com/records/483/preye-llc/9151db6c-59dc-4f2e-a763-ba41e58701f9

> FDA 483 for PReye, LLC on March 19, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PReye, LLC
- Inspection Date: 2026-03-19
- Product Type: drugs
- Office Name: FDA District Office — Denver, Colorado
- Summary: FREYE LLC, a repackager/relabeler of sterile drug products in Wheat Ridge, CO, was cited for significant deficiencies during an FDA inspection. Observations included inadequate aseptic processing environments, distribution of an OTC sterile drug product with unpermitted active ingredients, failure to perform identity testing on components, and a complete lack of an effective quality control unit. These conditions indicate a high risk of contamination and non-conforming products.

## Related Officers

- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.keypedia.com/companies/preye-llc/6e15ea7c-4f01-4a32-80d5-b002172db543

Office: https://www.keypedia.com/offices/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0