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1083738

Lohxa LLC — FEI 3027503130

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 22, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
North Oxford, MA (United States)

Facility

Other inspections at this facility

  • 1214910 (OAI Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1147010 (OAI Mon Jul 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
162621 CFR 211.130Procedures are written, and followed
187921 CFR 211.180(c)Records not made readily available to FDA
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
354721 CFR 211.46(b)Equipment for Environmental Control
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358521 CFR 211.110(a)Control procedures to monitor and validate performance
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.