Home / Inspections / 987439

987439

Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. — FEI 3008264702

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 9, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bangplee (Thailand)

Facility

Other inspections at this facility

  • 1217245 (VAI Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1180184 (NAI Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1034796 (NAI Fri Oct 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
180921 CFR 211.160(a)Following/documenting laboratory controls
202821 CFR 211.192Extent of discrepancy, failure investigations
241921 CFR 211.198(a)Complaint Handling Procedure
358521 CFR 211.110(a)Control procedures to monitor and validate performance
430321 CFR 211.67(b)Written procedures fail to include
434721 CFR 211.160(b)(2)In process materials - conformance to written specs