Hysan Pharmaceutical Co., Ltd., Chai Wan, Hong Kong SAR – FDA Inspections

Inspection records and compliance data for Hysan Pharmaceutical Co., Ltd. in Chai Wan. 4 FDA inspections on record, 2 Form 483s, last inspected June 12, 2025.

Company Profile

This profile covers Hysan Pharmaceutical Co., Ltd. based in Chai Wan, Hong Kong SAR.

FDA Inspection History

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

First inspected October 11, 2012. Last inspected June 12, 2025.

Most cited issue areas

Lack of written stability program2 inspections
Written procedures not established/followed2 inspections
Calibration - at intervals, written program, remedial action1 inspection

FDA inspections (4)

Date	Result	FDA center(s)	Insp. #
June 12, 2025	VAI	Human Drugs · Drug Quality Assurance	1274837
March 29, 2018	VAI	Human Drugs · Drug Quality Assurance	1047429
September 10, 2015	VAI	Human Drugs · Drug Quality Assurance	941851
October 11, 2012	VAI	Human Drugs · Drug Quality Assurance	822258

FDA documents

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

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