# FDA 483 - Sage Products, LLC - June 07, 2019

Source: https://www.keypedia.com/records/483/sage-products-llc/0f4e4fcb-6995-4997-81b9-53debec81f85

> FDA 483 for Sage Products, LLC on June 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sage Products, LLC
- Inspection Date: 2019-06-07
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Sage Products Inc in Cary, IL was inspected by the FDA from June 3-7, 2019, resulting in two observations. The inspection revealed significant issues with the firm's quality and laboratory systems. Specifically, the firm failed to adequately investigate unexplained discrepancies and critical alarms, and deviations from laboratory procedures were not properly recorded or justified.

## Related Documents

- [483 - 2025-07-11](https://www.keypedia.com/records/483/sage-products-llc/58b58227-fb97-42de-afc7-deb5822aff4f)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/vioela-j-caze/919a30c8-26e5-4908-a73c-4e8cba5692cf)
- [Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality](https://www.keypedia.com/people/emilie-e-kahn/fac179e5-478f-4e75-9632-40d921f44a8f)

Company: https://www.keypedia.com/companies/sage-products-llc/0f9d73bb-cc3e-4880-bea8-3496d8fd6397

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