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1177708

Midlab Incorporated — FEI 3001236208

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 5, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Athens, TN (United States)

Facility

Other inspections at this facility

  • 1249514 (OAI Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1021846 (NAI Wed May 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 767524 (NAI Tue Feb 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
145421 CFR 211.115(a)Reprocessing procedures not written or followed
184221 CFR 211.84(d)(1)Component identity verification
188521 CFR 211.165(b)Microbiological testing
191421 CFR 211.166(a)Lack of written stability program
358521 CFR 211.110(a)Control procedures to monitor and validate performance