FDA inspection

Rotem Industries Limited: FDA inspection ending Nov 7, 2019

FDA inspection 1110472 · Voluntary Action Indicated (VAI) · Dimona

Key facts

Inspection ID 1110472
Firm Rotem Industries Limited
FEI number 3008739573
Address Rotem Industrial Park, Mishor Yamin D.N.
City Dimona
Country Israel
Fiscal year 2020
Inspection end date Nov 7, 2019
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • None 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

Browse all FDA inspections