FDA inspection

OPK Biotech, LLC: FDA inspection ending Feb 15, 2005

FDA inspection 367768 · Voluntary Action Indicated (VAI) · Cambridge, MA

Key facts

Inspection ID 367768
Firm OPK Biotech, LLC
FEI number 1222147
Address 11 & 39 Hurley Street
City Cambridge
State MA
ZIP 02141-2112
Fiscal year 2005
Inspection end date Feb 15, 2005
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

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