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1100702

The Brigham and Women's Hospital, Inc. — FEI 3012030543

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 22, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Boston, MA (United States)

Facility

Other inspections at this facility

  • 1203279 (NAI Tue Apr 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152063 (OAI Thu Sep 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 953620 (VAI Thu Dec 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891621 (VAI Fri Aug 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1775921 CFR 212.20(c)Adverse effects of changes made
1776321 CFR 212.20(d)Determination need for investigation
1776421 CFR 212.20(e)Written QA procedures established, followed
1785121 CFR 212.60(c)Analytical methods
2137621 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination