FDA inspection

American Ortho-Tech (P) Ltd.: FDA inspection ending Dec 5, 2012

FDA inspection 812414 · Voluntary Action Indicated (VAI) · Chennai, Tambaram

Key facts

Inspection ID 812414
Firm American Ortho-Tech (P) Ltd.
FEI number 3004458220
Address Plot No. A9, Phase II, MEPZ/SEZ
City Chennai, Tambaram
Country India
Fiscal year 2013
Inspection end date Dec 5, 2012
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

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
  • 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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