FDA inspection
Isomedix Operations Inc.: FDA inspection ending May 6, 2008
FDA inspection 520260 · No Action Indicated (NAI) · Libertyville, IL
Key facts
| Inspection ID | 520260 |
|---|---|
| Firm | Isomedix Operations Inc. |
| FEI number | 1450662 |
| Address | 1880 Industrial Dr |
| City | Libertyville |
| State | IL |
| ZIP | 60048-9439 |
| Fiscal year | 2008 |
| Inspection end date | May 6, 2008 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev|Drug Quality Assurance|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Monit of Marketed Animal Drug,Feed &Dev |
| Product type | Biologics, Devices, Drugs |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 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