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579571

Pharma Nobis LLC — FEI 1611206

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 24, 2009
Fiscal Year
2009
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))
  • 934827 (OAI Wed Jul 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
180921 CFR 211.160(a)Following/documenting laboratory controls
191221 CFR 211.166(a)Written program not followed
430321 CFR 211.67(b)Written procedures fail to include
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
457621 CFR 211.192No written record of investigation