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1245286

Micra Biotechnologies, Inc. — FEI 1000122226

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 2, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
River Edge, NJ (United States)

Facility

Other inspections at this facility

  • 1010301 (VAI Fri Apr 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 916518 (VAI Tue Mar 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819797 (VAI Mon Mar 04 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 765142 (VAI Mon Jan 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 672872 (NAI Fri Jul 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
142021 CFR 211.42(c)(9)Control / Lab Operations Area
180921 CFR 211.160(a)Following/documenting laboratory controls
360321 CFR 211.160(b)Scientifically sound laboratory controls