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918971

Bell-More Labs, Inc. — FEI 1150023

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 13, 2015
Fiscal Year
2015
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))
  • 1066757 (OAI Wed Sep 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979342 (OAI Thu May 26 2016 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
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
143321 CFR 211.42(c)(10)(iii)Air Supply
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
440921 CFR 211.194(a)(4)Data secured in course of each test