Home / Inspections / 1030174

1030174

DermaRite Industries, LLC — FEI 1000526900

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 30, 2017
Fiscal Year
2018
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))
  • 1250450 (OAI Tue Apr 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068298 (VAI Wed Oct 10 2018 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
108621 CFR 211.22(b)Adequate lab facilities not available
117721 CFR 211.63Equipment Design, Size and Location
191221 CFR 211.166(a)Written program not followed
363221 CFR 211.170(b)Annual visual exams of drug products
436921 CFR 211.188(b)(11)Identification of persons involved, each significant step
438921 CFR 211.198(a)Procedures to be written and followed