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483
•Eugia US Manufacturing LLC•December 22, 2023

Eugia US Manufacturing LLC – FDA 483, Dec 22, 2023

Record Details

Eugia US Manufacturing LLC in East Windsor, NJ, was inspected and cited for significant deficiencies across its manufacturing operations. The inspection revealed a dysfunctional quality control unit, inadequate aseptic processing controls, and unsuitable facility conditions. Furthermore, the firm demonstrated poor computer system controls, uninvestigated product deterioration, and scientifically unsound laboratory testing practices.

Company
Eugia US Manufacturing LLC
Inspection date
December 22, 2023
Product type
drugs
Office
New Jersey District Office
People
  • Yoriann M. Cabrera Bartolomei
  • Ruben C. Quintana
  • Daniel L. Zheng (M.S., Consumer Safety Officer at FDA)
  • James R. Birkenstamm
View Company Profile

ID · b4c5710f-9221-4deb-b08c-7ad35c549b99

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