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1136806

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

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 17, 2021
Fiscal Year
2021
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))
  • 1097892 (NAI Tue Jul 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063720 (VAI Fri Aug 17 2018 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
363221 CFR 211.170(b)Annual visual exams of drug products
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications