FDA inspection
OPK Biotech, LLC: FDA inspection ending Nov 14, 2002
FDA inspection 248080 · Voluntary Action Indicated (VAI) · Cambridge, MA
Key facts
| Inspection ID | 248080 |
|---|---|
| Firm | OPK Biotech, LLC |
| FEI number | 1222147 |
| Address | 11 & 39 Hurley Street |
| City | Cambridge |
| State | MA |
| ZIP | 02141-2112 |
| Fiscal year | 2003 |
| Inspection end date | Nov 14, 2002 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | 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|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit|Pre-Apprvl of Animal Drugs/Food Addit |
| Product type | Drugs |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- No 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