FDA inspection

Abbott Medical: FDA inspection ending Nov 10, 2009

FDA inspection 635939 · Voluntary Action Indicated (VAI) · Caguas, PR

Key facts

Inspection ID 635939
Firm Abbott Medical
FEI number 2648612
Address Lot 20 B St, Caguas West Industrial Park
City Caguas
State PR
ZIP 00725
Country United States
Fiscal year 2010
Inspection end date Nov 10, 2009
Classification Voluntary Action Indicated (VAI)
Project area Project Evaluation: 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
  • 10–99 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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