Company
United StatesMomenta Pharmaceuticals, Inc., Cambridge, MA – FDA Inspections
Inspection records and compliance data for Momenta Pharmaceuticals, Inc. in Cambridge, Massachusetts. 4 FDA inspections on record, 1 Form 483, last inspected May 15, 2017.
Company Profile
This profile covers Momenta Pharmaceuticals, Inc. based in Cambridge, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected November 20, 2009. Last inspected May 15, 2017.
Most cited issue areas
- Calibration - at intervals, written program, remedial action1 inspection
- Deviations from laboratory control requirements1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 15, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1015902 |
| April 11, 2014 | NAI | Human Drugs · Drug Quality Assurance | 874279 |
| June 8, 2012 | VAI | Human Drugs · Drug Quality Assurance | 786187 |
| November 20, 2009 | NAI | Human Drugs · Drug Quality Assurance | 630475 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Momenta Pharmaceuticals, Inc.
FEI Number
3005948218
Address
301 Binney St, Cambridge, Massachusetts 02142, United States
Country
United States
ID: c21f791e-0071-4f33-81c2-32205123a6cd