Home / Inspections / 934827

934827

Pharma Nobis LLC — FEI 1611206

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 1, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Texarkana, TX (United States)

Facility

Other inspections at this facility

  • 1254643 (VAI Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1121963 (OAI Fri Mar 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067901 (NAI Tue Aug 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061996 (NAI Mon Mar 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 841659 (VAI Wed Jul 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121921 CFR 211.67(b)(2)Cleaning SOPs/schedules
122721 CFR 211.67(c)Cleaning/maintenance records not kept
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
189021 CFR 211.165(e)Test methods
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures
430321 CFR 211.67(b)Written procedures fail to include
434421 CFR 211.160(b)(1)Sampling and testing procedures described
457621 CFR 211.192No written record of investigation