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1232208

Citra Labs, LLC — FEI 1216032

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 8, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Braintree, MA (United States)

Facility

Other inspections at this facility

  • 1114950 (NAI Fri Dec 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026851 (VAI Wed Sep 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 907313 (VAI Fri Nov 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 883492 (VAI Fri Jun 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 756503 (VAI Fri Dec 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
135821 CFR 211.100(b)SOPs not followed / documented
356521 CFR 211.58Buildings not maintained in good state of repair