# FDA 483 - Agnitio Inc - June 04, 2021

Source: https://www.globalkeysolutions.net/records/483/agnitio-inc/8e320096-d2d1-4b8d-be74-fe35ede54c4f

> FDA 483 for Agnitio Inc on June 04, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Agnitio Inc
- Inspection Date: 2021-06-04
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Agnitio Inc., an OTC Human Drug Manufacturer in Appleton, WI, was inspected by the FDA from June 1-4, 2021. The inspection revealed a significant issue with the firm's stability program, specifically that the Quality unit failed to properly review and verify stability data for certain products. This indicates a potential lapse in quality control for drug products.

## Related Officers

- [Norman K. Starks](https://www.globalkeysolutions.net/people/norman-k-starks/4b8776e0-f96e-429c-94d1-40c0369f5378)

Company: https://www.globalkeysolutions.net/companies/agnitio-inc/6bcd09b9-e002-45bf-805c-0e4474b1bdfb

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669