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1287054

Apozeal Pharmaceuticals Inc. — FEI 3004536846

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 15, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Levittown, PA (United States)

Facility

Other inspections at this facility

  • 1161191 (NAI Wed Dec 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1085686 (OAI Tue Apr 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073461 (NAI Fri Nov 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026757 (NAI Wed Apr 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 807963 (VAI Wed Nov 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls