Home / Inspections / 785318

785318

CorePharma, LLC — FEI 3002535019

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 11, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Middlesex, NJ (United States)

Facility

Other inspections at this facility

  • 1280399 (NAI Thu Aug 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1240419 (NAI Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1087306 (NAI Fri Mar 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029942 (NAI Fri Oct 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980585 (NAI Thu Aug 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
107921 CFR 211.22(a)Contract drug products--lack of responsibility
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
363921 CFR 211.204Returned drug procedures in writing and followed
430521 CFR 211.68(b)Backup data not assured as exact and complete