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1063720

PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC — FEI 3007343300

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 17, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Guayama, PR (United States)

Facility

Other inspections at this facility

  • 1231508 (VAI Mon May 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1136806 (VAI Wed Mar 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097892 (NAI Tue Jul 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 996282 (NAI Tue Oct 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 908081 (VAI Mon Nov 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
435021 CFR 211.160(b)(3)Drug products-sampling procedures/specifications