FDA inspection

Spatz FGIA, Inc: FDA inspection ending Sep 25, 2019

FDA inspection 1107557 · Voluntary Action Indicated (VAI) · Ra'Anana

Key facts

Inspection ID	1107557
Firm	Spatz FGIA, Inc
FEI number	3015409025
Address	13, Ha-Ta'As
City	Ra'Anana
Fiscal year	2019
Inspection end date	Sep 25, 2019
Classification	Voluntary Action Indicated (VAI)
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: 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: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical 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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