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FDA Inspection 1020421 — Roche Molecular Systems, Inc.

Roche Molecular Systems, Inc. — FEI 2243471

The FDA completed an inspection of Roche Molecular Systems, Inc. on July 19, 2017 in Branchburg, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 19, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Branchburg, NJ (United States)

Facility

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  • 1224711 (VAI Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100926 (NAI Wed Jul 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1027092 (NAI Mon Jul 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979955 (NAI Wed Jul 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources