FDA inspection

Nitinol Devices and Components Costa Rica, S.R.L.: FDA inspection ending May 12, 2016

FDA inspection 972428 · Voluntary Action Indicated (VAI) · El Coyol

Key facts

Inspection ID 972428
Firm Nitinol Devices and Components Costa Rica, S.R.L.
FEI number 3009018440
Address Coyol Free Zone, Building 14
City El Coyol
Country Costa Rica
Fiscal year 2016
Inspection end date May 12, 2016
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None 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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