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1250450

DermaRite Industries, LLC — FEI 1000526900

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 8, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
North Bergen, NJ (United States)

Facility

Other inspections at this facility

  • 1276408 (NAI Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068298 (VAI Wed Oct 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030174 (VAI Mon Oct 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915250 (VAI Mon Feb 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 780318 (VAI Thu May 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies