FDA Inspection 1015902 — Momenta Pharmaceuticals, Inc.
The FDA completed an inspection of Momenta Pharmaceuticals, Inc. on May 15, 2017 in Cambridge, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cambridge, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |