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1066757

Bell-More Labs, Inc. — FEI 1150023

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 26, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hampstead, MD (United States)

Facility

Other inspections at this facility

  • 1143441 (OAI Mon Jun 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979342 (OAI Thu May 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918971 (VAI Fri Mar 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 828556 (VAI Fri Apr 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 707663 (VAI Wed Jan 26 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
142121 CFR 211.42(c)(10)Aseptic Processing Area
143321 CFR 211.42(c)(10)(iii)Air Supply
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
240121 CFR 211.194(a)(4)Complete Test Data
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation