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948716

Cetylite Industries, Inc. — FEI 2242327

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 19, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pennsauken, NJ (United States)

Facility

Other inspections at this facility

  • 1266077 (VAI Mon Apr 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1256150 (VAI Mon Dec 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1198788 (OAI Thu Mar 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152977 (OAI Fri Sep 24 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053508 (VAI Tue May 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
145421 CFR 211.115(a)Reprocessing procedures not written or followed
172821 CFR 211.87Retest of approved components/containers/closures
189121 CFR 211.165(f)Failing drug products not rejected
358521 CFR 211.110(a)Control procedures to monitor and validate performance
457621 CFR 211.192No written record of investigation