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1065592

Neutraderm, Inc. — FEI 3006402197

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 14, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chatsworth, CA (United States)

Facility

Other inspections at this facility

  • 1192551 (VAI Fri Dec 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980025 (VAI Fri Jul 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 831933 (VAI Fri Apr 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754210 (VAI Fri Dec 02 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 595797 (VAI Thu Jul 02 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
108621 CFR 211.22(b)Adequate lab facilities not available
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
191221 CFR 211.166(a)Written program not followed
194221 CFR 211.180(e)Records reviewed annually
434921 CFR 211.160(b)(2)In-process samples representative, identified properly
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action