1171766

The General Hospital Corporation — FEI 3010164233

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 13, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Boston, MA (United States)

Citations

IDCFRDescription
1776321 CFR 212.20(d)Determination need for investigation
1776421 CFR 212.20(e)Written QA procedures established, followed
1781221 CFR 212.50Adequate controls (general)
2137321 CFR 212.30(b)Equipment procedures
2137621 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination