Orca1

FDA inspection

ARJ Medical, Inc. / Gulf Coast Scientific Inc: FDA inspection ending Jan 10, 2020

FDA inspection 1115249 · No Action Indicated (NAI) · Oldsmar, Florida

Key facts

Inspection ID 1115249
Firm ARJ Medical, Inc. / Gulf Coast Scientific Inc
FEI number 3004577174
Address 209 State St E
City Oldsmar
State Florida
ZIP 34677
Fiscal year 2020
Inspection end date Jan 10, 2020
Classification No Action Indicated (NAI)
Project area Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: 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Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: 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.

Other inspections at this establishment

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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