FDA inspection

Novel Laboratories, Inc. d.b.a LUPIN: FDA inspection ending Dec 21, 2018

FDA inspection 1075292 · Official Action Indicated (OAI) · Somerset, NJ

Key facts

Inspection ID 1075292
Firm Novel Laboratories, Inc. d.b.a LUPIN
FEI number 3006271438
Address 400 Campus Dr
City Somerset
State NJ
ZIP 08873-1145
Fiscal year 2019
Inspection end date Dec 21, 2018
Classification Official Action Indicated (OAI)
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|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation
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
  • 10–99 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

Browse all FDA inspections