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FDA inspection

Janssen Ortho LLC: FDA inspection ending Dec 17, 2001

FDA inspection 197179 · Voluntary Action Indicated (VAI) · Manati, PR

Key facts

Inspection ID 197179
Firm Janssen Ortho LLC
FEI number 2650078
Address Road # 2 Km 45.6 Bo. Campo Alegre
City Manati
State PR
ZIP 00674
Fiscal year 2002
Inspection end date Dec 17, 2001
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation|Drug Quality Assurance|New Drug Evaluation
Product type Devices, Drugs

At a glance

  • None 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.

Other inspections at this establishment

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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