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• LSNE-Manchester
• LSNE-Bedford
• 25 Commerce Drive
• 19 Harvey Road
• LSNE-León
Medical Device Manufacturing Facility
Commercial Services
1 Sundial Avenue, Manchester, NH 03103
2 0 0 4 2 0 0 6 2 0 1 1 2 0 1 3 2 0 1 6
FDA General GMP Inspection
FDA General GMP Inspection
FDA General GMP Inspection
(QSIT Inspection)
FDA General GMP Inspection
FDA Pre-Approval Inspection
2 0 0 2
FDA General GMP Inspection
1 9 9 9
FDA General GMP Inspection
2 0 1 9
ANVISA GMP Inspection
1 9 9 7
Established
Drug Product & Medical Device Manufacturing Facility
Clinical and Commercial Services
25 Commerce Drive, Bedford, NH 03110
Drug Product Manufacturing Facility
Commercial Services
19 Harvey Road, Bedford, NH 03110
*Inspection performed under campus designation with 19 Harvey Road
2 0 1 3 2 0 1 4 2 0 1 5 2 0 1 7 2 0 1 8
MHRA Inspection FDA Pre-Approval &
GMP Inspection
FDA General
GMP Inspection*
FDA Pre-Approval &
GMP Inspection
2 0 1 1
Established
FDA Pre-Approval &
GMP Inspection
*Inspection performed under campus designation with 25 Commerce Drive
2 0 1 1 2 0 1 2 2 0 1 4 2 0 1 7 2 0 1 8
FDA General GMP Inspection
FDA Pre-Approval & GMP Inspection
FDA General GMP Inspection*
2 0 0 92 0 0 5
Established
FDA Pre-Approval (QC) & GMP Inspection
FDA Pre-Approval & GMP Inspection
FDA Pre-Approval & GMP Inspection
Drug Product Manufacturing Facility
Clinical and Commercial Services
León, Spain
2 0 1 9 2 0 2 0
FDA Pre-Approval & GMP Inspection
Acquired in June
FDA Pre-Approval Inspection
2 0 1 42 0 1 3
AEMPS Inspection
Established
Previous Ownership
• For more information about our regulatory history and service offerings.
603.668.5763
mailto:[email protected]