FDA inspection
Organon USA Inc.: FDA inspection ending Jun 27, 2003
FDA inspection 281223 · Official Action Indicated (OAI) · West Orange, NJ
Key facts
| Inspection ID | 281223 |
|---|---|
| Firm | Organon USA Inc. |
| FEI number | 2211109 |
| Address | 375 Mount Pleasant Ave |
| City | West Orange |
| State | NJ |
| ZIP | 07052-2724 |
| Fiscal year | 2003 |
| Inspection end date | Jun 27, 2003 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|New Drug Evaluation|Post Mrkt Surv & Epid: Human Drugs|New Drug Evaluation|Post Mrkt Surv & Epid: Human Drugs|New Drug Evaluation|Post Mrkt Surv & Epid: Human Drugs|New Drug Evaluation|Post Mrkt Surv & Epid: Human Drugs|New Drug Evaluation|Post Mrkt Surv & Epid: Human Drugs|New Drug Evaluation|Post Mrkt Surv & Epid: Human Drugs|New Drug 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| Product type | Drugs |
| Warning letter | UCM147745 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data