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977965

Xttrium Laboratories, Inc. — FEI 3008436464

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 11, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mount Prospect, IL (United States)

Facility

Other inspections at this facility

  • 1273417 (OAI Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1234354 (VAI Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1230448 (NAI Tue Feb 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046665 (VAI Thu Mar 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985062 (VAI Wed May 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
122321 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
178721 CFR 211.80(a)Procedures To Be in Writing
180221 CFR 211.84(b)Representative Samples
241921 CFR 211.198(a)Complaint Handling Procedure
360321 CFR 211.160(b)Scientifically sound laboratory controls