FDA Inspection 610013 — Genzyme Ltd.
The FDA completed an inspection of Genzyme Ltd. on August 6, 2009 in Oxford. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 6, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Oxford (United Kingdom)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 9095 | 21 CFR 600.80(c)(1)(i) | Reporting Requirements - 15-day alert |