FDA inspection

OPK Biotech LLC: FDA inspection ending Nov 7, 2002

FDA inspection 246343 · Voluntary Action Indicated (VAI) · Souderton, PA

Key facts

Inspection ID 246343
Firm OPK Biotech LLC
FEI number 3001236631
Address 674 Souder Rd
City Souderton
State PA
ZIP 18964-2423
Fiscal year 2003
Inspection end date Nov 7, 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

  • None 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

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