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986013

KRS Global Biotechnology, Inc — FEI 3006412304

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 31, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Boca Raton, FL (United States)

Facility

Other inspections at this facility

  • 1099535 (OAI Wed Aug 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029456 (VAI Mon Oct 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 870308 (OAI Mon Mar 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
115921 CFR 211.28(a)Clothing appropriate for duties performed
143321 CFR 211.42(c)(10)(iii)Air Supply
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
18008FDCA 503B(a)(10)Drug product label, outsourcer facility