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881607

Ortho Biologics, LLC — FEI 1000110299

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 23, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Manati, PR (United States)

Facility

Other inspections at this facility

  • 1118152 (NAI Fri Jan 24 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1089445 (NAI Thu Apr 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022029 (NAI Thu Jul 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015645 (NAI Fri May 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963080 (VAI Thu Feb 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121921 CFR 211.67(b)(2)Cleaning SOPs/schedules
202721 CFR 211.192Investigations of discrepancies, failures
440221 CFR 211.192Written record of investigation incomplete
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications