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1152063

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

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 16, 2021
Fiscal Year
2021
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))
  • 1100702 (OAI Thu Aug 22 2019 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
1776321 CFR 212.20(d)Determination need for investigation
1776421 CFR 212.20(e)Written QA procedures established, followed
1785021 CFR 212.60(b)Lab sampling and test procedures
2137321 CFR 212.30(b)Equipment procedures
2137621 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination