FDA inspection

Axelgard Mfg Co Ltd: FDA inspection ending Aug 28, 2019

FDA inspection 1121812 · No Action Indicated (NAI) · Fallbrook, CA

Key facts

Inspection ID 1121812
Firm Axelgard Mfg Co Ltd
FEI number 1000603528
Address 520 Industrial Way
City Fallbrook
State CA
ZIP 92028-2244
Fiscal year 2019
Inspection end date Aug 28, 2019
Classification No Action Indicated (NAI)
Project area Compliance: Medical Devices
Product type Devices

At a glance

  • None Citations
  • None 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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