Home / Inspections / 1053508

1053508

Cetylite Industries, Inc. — FEI 2242327

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 29, 2018
Fiscal Year
2018
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))
  • 948716 (VAI Thu Nov 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1002221 CFR 310.305(a)Failure to develop written procedures
110521 CFR 211.22(d)Procedures not in writing, fully followed
113621 CFR 211.25(c)Inadequate number of personnel
176721 CFR 211.137(a)Expiration date lacking
189121 CFR 211.165(f)Failing drug products not rejected
360321 CFR 211.160(b)Scientifically sound laboratory controls
430721 CFR 211.80(d)Status of Each Lot Identified
670621 CFR 310.305(c)(1)(i)Late submission