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1085686

Apozeal Pharmaceuticals Inc. — FEI 3004536846

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 9, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Levittown, PA (United States)

Facility

Other inspections at this facility

  • 1287054 (OAI Wed Oct 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1161191 (NAI Wed Dec 15 2021 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
117721 CFR 211.63Equipment Design, Size and Location
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
145021 CFR 211.113(a)Procedures for non-sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
2129521 CFR 211.110(b)In-process conformity - examination, sample testing
361121 CFR 211.160(b)(3)Acceptance of drug products