FDA inspection

Laboratorios Dentales De Zona Franca, S.A.: FDA inspection ending Jan 30, 2020

FDA inspection 1117348 · Official Action Indicated (OAI) · San Isidro Del Guarco

Key facts

Inspection ID 1117348
Firm Laboratorios Dentales De Zona Franca, S.A.
FEI number 3001295407
Address Entrada A Higuito
City San Isidro Del Guarco
Country Costa Rica
Fiscal year 2020
Inspection end date Jan 30, 2020
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices
Warning letter 607719

At a glance

  • 1–9 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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