Shionogi Pharma Co., Ltd., Amagasaki, Japan – FDA Inspections

Inspection records and compliance data for Shionogi Pharma Co., Ltd. in Amagasaki. 4 FDA inspections on record, last inspected April 05, 2024.

Company Profile

This profile covers Shionogi Pharma Co., Ltd. based in Amagasaki, Japan.

FDA Inspection History

FDA inspections: 4
OAI: 0
VAI: 2
NAI: 2
Form 483s: 0
Warning letters: 0

First inspected February 15, 2012. Last inspected April 5, 2024.

Most cited issue areas

Adequate lab facilities not available1 inspection
Complete test data included in records1 inspection
Extent of discrepancy, failure investigations1 inspection

FDA inspections (4)

Date	Result	FDA center(s)	Insp. #
April 5, 2024	NAI	Human Drugs · Drug Quality Assurance	1238718
June 3, 2016	VAI	Human Drugs · Drug Quality Assurance	974314
February 15, 2012	NAI	Human Drugs · Drug Quality Assurance	777796
February 15, 2012	VAI	Human Drugs · Drug Quality Assurance	777783

FDA documents

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

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