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1026851

Citra Labs, LLC — FEI 1216032

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 27, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Braintree, MA (United States)

Facility

Other inspections at this facility

  • 1232208 (VAI Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114950 (NAI Fri Dec 13 2019 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
143521 CFR 211.42(c)(10)(v)Cleaning System
197521 CFR 211.182Written records kept in individual logs
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications