FDA inspection

Janssen Ortho LLC: FDA inspection ending Apr 13, 2005

FDA inspection 374875 · Voluntary Action Indicated (VAI) · Manati, PR

Key facts

Inspection ID 374875
Firm Janssen Ortho LLC
FEI number 2650078
Address Road # 2 Km 45.6 Bo. Campo Alegre
City Manati
State PR
ZIP 00674
Fiscal year 2005
Inspection end date Apr 13, 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|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation
Product type Drugs

At a glance

  • 1–9 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

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