FDA Inspection 985381 — Genzyme Corporation
The FDA completed an inspection of Genzyme Corporation on Aug 18, 2016 in Northborough, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 18, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Northborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4576 | 21 CFR 211.192 | No written record of investigation |