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483
•Sage Products, LLC•June 7, 2019

Sage Products, LLC – FDA 483, Jun 7, 2019

Record Details

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.

Company
Sage Products, LLC
Inspection date
June 7, 2019
Product type
drugs
Office
Chicago District Office
People
  • Vioela J. Caze (issuing_officer)
  • Emilie E. Kahn (Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality)
View Company Profile

ID · 0f4e4fcb-6995-4997-81b9-53debec81f85

Other documents for Sage Products, LLC
  • 483 - 2025-07-11July 11, 2025
  • EIR - 2016-09-01September 1, 2016

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