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1193271

Health Pharma USA LLC — FEI 3013856804

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 20, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Rahway, NJ (United States)

Facility

Other inspections at this facility

  • 1237491 (OAI Wed Jul 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152299 (OAI Wed Sep 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1092057 (OAI Mon Jun 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
125621 CFR 211.68(b)Backup file not maintained
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
191221 CFR 211.166(a)Written program not followed
201121 CFR 211.188(a)Accurate reproduction
202321 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
354721 CFR 211.46(b)Equipment for Environmental Control
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
432021 CFR 211.84(d)(6)Microbiological Contamination Exam
434221 CFR 211.142(b)Storage under appropriate conditions