FDA inspection

CEA Global Dominicana d.b.a. Nissha Medical Technologies: FDA inspection ending Apr 14, 2016

FDA inspection 969808 · Voluntary Action Indicated (VAI) · San Pedro de Macoris

Key facts

Inspection ID 969808
Firm CEA Global Dominicana d.b.a. Nissha Medical Technologies
FEI number 3006891611
Address Zona Franca Industrial
City San Pedro de Macoris
Country Dominican Republic (the)
Fiscal year 2016
Inspection end date Apr 14, 2016
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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