FDA inspection

Degania Medical Devices Pvt. Ltd.: FDA inspection ending Aug 29, 2014

FDA inspection 899016 · Official Action Indicated (OAI) · Gurgaon

Key facts

Inspection ID 899016
Firm Degania Medical Devices Pvt. Ltd.
FEI number 3005483737
Address Plot No 251, Imt Manesar
City Gurgaon
Country India
Fiscal year 2014
Inspection end date Aug 29, 2014
Classification Official Action Indicated (OAI)
Project area Postmarket Assurance: Devices
Product type Devices
Warning letter 443502

At a glance

  • None Citations
  • 1–9 Posted citations
  • Yes 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

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