Home / Inspections / 1047429

1047429

Hysan Pharmaceutical Co., Ltd. — FEI 3004087499

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 29, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chai Wan (Hong Kong SAR)

Facility

Other inspections at this facility

  • 1274837 (VAI Thu Jun 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941851 (VAI Thu Sep 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 822258 (VAI Thu Oct 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
149521 CFR 211.122(a)Written procedures describing in detail
191421 CFR 211.166(a)Lack of written stability program
197521 CFR 211.182Written records kept in individual logs
200721 CFR 211.186(a)Signature and checking of records -- 2 persons
203521 CFR 211.194(e)Stability testing records not included