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FDA inspection

Janssen Cilag Manufacturing LLC: FDA inspection ending Feb 21, 2008

FDA inspection 511580 · No Action Indicated (NAI) · Gurabo, PR

Key facts

Inspection ID 511580
Firm Janssen Cilag Manufacturing LLC
FEI number 3006244497
Address State Road 933 Km. 0.1, Mamey Ward
City Gurabo
State PR
ZIP 00778
Fiscal year 2008
Inspection end date Feb 21, 2008
Classification No Action Indicated (NAI)
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

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 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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