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916518

Micra Biotechnologies, Inc. — FEI 1000122226

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 10, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
River Edge, NJ (United States)

Facility

Other inspections at this facility

  • 1245286 (VAI Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010301 (VAI Fri Apr 21 2017 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
180921 CFR 211.160(a)Following/documenting laboratory controls
360221 CFR 211.160(a)Deviations from laboratory control requirements
440521 CFR 211.194(a)(2)Statement of methods and data
440721 CFR 211.194(a)(2)Reference and method not stated
441321 CFR 211.194(a)(8)Second person sign off