# FDA 483 - Davion Inc - July 17, 2024

Source: https://www.keypedia.com/records/483/davion-inc/e628779a-4315-4206-8137-eb6153ed1161

> FDA 483 for Davion Inc on July 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Davion Inc
- Inspection Date: 2024-07-17
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Davion Inc. in North Brunswick, NJ, was inspected and cited for multiple significant deficiencies in its manufacturing and quality control processes for over-the-counter drug products. Observations included failures in quality unit oversight of contract lab testing, inadequate storage conditions and temperature mapping for raw materials and finished products, and deficient annual drug product review procedures. Additionally, the firm lacked proper controls for raw material sampling, leading to potential contamination risks.

## Related Officers

- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

Company: https://www.keypedia.com/companies/davion-inc/755da534-863f-43e7-86bf-b40341b1c9ed

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248