FDA inspection

DeRoyal Cientifica De Latinoamerica S.R.L.: FDA inspection ending Feb 28, 2013

FDA inspection 821533 · Official Action Indicated (OAI) · Heredia

Key facts

Inspection ID 821533
Firm DeRoyal Cientifica De Latinoamerica S.R.L.
FEI number 3006469671
Address Box 180-3006, 602 Parkway
City Heredia
Country Costa Rica
Fiscal year 2013
Inspection end date Feb 28, 2013
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices
Warning letter 406127

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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