Shalon Chemical Industries Ltd., Kiryat Gat, Israel – FDA Inspections

Inspection records and compliance data for Shalon Chemical Industries Ltd. in Kiryat Gat. 2 FDA inspections on record, 2 Form 483s, last inspected November 20, 2017.

Company Profile

This profile covers Shalon Chemical Industries Ltd. based in Kiryat Gat, Israel.

FDA Inspection History

FDA inspections: 2
OAI: 0
VAI: 1
NAI: 0
Unclassified: 1
Form 483s: 2
Warning letters: 0

First inspected October 13, 2016. Last inspected November 20, 2017.

Most cited issue areas

Calibration procedures - content1 inspection
Design Validation - Risk analysis not performed/inadequate1 inspection
Documentation1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
November 20, 2017	VAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	1032158
October 13, 2016	Not classified	Medical Devices & Rad Health · Compliance: Devices	988933

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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