FDA Inspection
Momenta Pharmaceuticals, Inc.Momenta Pharmaceuticals, Inc. – FDA Inspection, May 15, 2017
Record Details
This FDA Inspection record concerns Momenta Pharmaceuticals, Inc., with an inspection on May 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6169cbb0-b8d2-48ee-bf15-2a27dd732f1f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015902
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
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Other FDA inspections of Momenta Pharmaceuticals, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 8, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 20, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Momenta Pharmaceuticals, Inc.
- FDA Inspection 874279 - 2014-04-11
- FDA Inspection 786187 - 2012-06-08
- FDA Inspection 630475 - 2009-11-20
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