# FDA 483 - Preventics, Inc. - April 18, 2025

Source: https://www.globalkeysolutions.net/records/483/preventics-inc/649200d3-5e1a-4bde-b01b-bb47030452ab

> FDA 483 for Preventics, Inc. on April 18, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Preventics, Inc.
- Inspection Date: 2025-04-18
- Product Type: other
- Office Name: Denver District Office
- Summary: An FDA inspection of Preventics, Inc. dba Legere Pharmaceuticals in Scottsdale, AZ, revealed significant deficiencies across its dietary supplement manufacturing, packaging, and labeling operations. The firm failed to establish and adhere to critical specifications for products, packaging, and components, and exhibited widespread issues with master and batch production records. Furthermore, the inspection identified severe lapses in quality control procedures, product complaint handling, returned product management, and sanitation practices, indicating a systemic failure to comply with good manufacturing practices.

## Related Officers

- [Ciara J. Bajulai Austin](https://www.globalkeysolutions.net/people/ciara-j-bajulai-austin/f61fdada-8482-4adb-b5bf-f9eafaa572a1)

Company: https://www.globalkeysolutions.net/companies/preventics-inc/f9047274-5276-4e91-8616-3febe14f9850

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face
