FDA Inspection 586238 — Pfizer, Inc.
The FDA completed an inspection of Pfizer, Inc. on Jun 3, 2009 in Groton, CT. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 3, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Groton, CT (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7410 | 21 CFR 312.53(a) | Investigator selection |
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7555 | 21 CFR 312.53(d) | Selecting monitors |