FDA inspection

Greatbatch Medical S. De R.L. De C.V.: FDA inspection ending Aug 15, 2019

FDA inspection 1099650 · Voluntary Action Indicated (VAI) · Tijuana

Key facts

Inspection ID 1099650
Firm Greatbatch Medical S. De R.L. De C.V.
FEI number 3007882731
Address Boulevard Licenciado Hector Teran Teran 20120, Parque Industrial Ciudad Industrial, Tijuana
City Tijuana
Country Mexico
Fiscal year 2019
Inspection end date Aug 15, 2019
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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