Home / Inspections / 1187498

1187498

Yusef Manufacturing Laboratories, LLC — FEI 3004845420

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 4, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Clearfield, UT (United States)

Facility

Other inspections at this facility

  • 1152591 (OAI Fri Sep 24 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1103172 (OAI Fri Sep 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984351 (OAI Thu May 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 713517 (VAI Fri Feb 25 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
145021 CFR 211.113(a)Procedures for non-sterile drug products
180321 CFR 211.84(b)Representative Samples Criteria
184221 CFR 211.84(d)(1)Component identity verification
189021 CFR 211.165(e)Test methods
191221 CFR 211.166(a)Written program not followed
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures
239921 CFR 211.194(a)(2)Laboratory Test Method Verification
430521 CFR 211.68(b)Backup data not assured as exact and complete
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action