FDA Device Entity Profile: Takeda Pharmaceuticals U.S.A., Inc.

Known Identifiers & Locations

FEI Numbers 3002669612, 3002806503, 3009340644, 3015054258, 3016418550, 3016938816

Owner Operator Numbers 10049748, 10051446, 10079762

Locations Covered Cambridge, MA, US; Lessines Hainaut, BE; Lexington, MA, US; Thousand Oaks, CA, US; VIENNA Wien, AT

Registered Establishments (6)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3002806503	Baxalta Belgium Manufacturing SA	Lessines Hainaut, BE	Export Device to the United States But Perform No Other Operation on Device	View Details
3009340644	SHIRE HUMAN GENETIC THERAPIES, INC.	Lexington, MA, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
3015054258	SHIRE HUMAN GENETIC THERAPIES, INC.	Thousand Oaks, CA, US	Repack or Relabel Medical Device	View Details
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US	Manufacture Medical Device	View Details
3016938816	Takeda Pharmaceuticals U.S.A., Inc.	Lexington, MA, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
9616848	Takeda Manufacturing Austria AG	VIENNA Wien, AT	Export Device to the United States But Perform No Other Operation on Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

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