FDA inspection
OPK Biotech, LLC: FDA inspection ending Feb 1, 2007
FDA inspection 460499 · Voluntary Action Indicated (VAI) · Cambridge, MA
Key facts
| Inspection ID | 460499 |
|---|---|
| Firm | OPK Biotech, LLC |
| FEI number | 1222147 |
| Address | 11 & 39 Hurley Street |
| City | Cambridge |
| State | MA |
| ZIP | 02141-2112 |
| Fiscal year | 2007 |
| Inspection end date | Feb 1, 2007 |
| Classification | Voluntary Action Indicated (VAI) |
| 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|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev|Monit of Marketed Animal Drug,Feed &Dev |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No 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