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1285106

Alcami Carolinas Corporation — FEI 1049418

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 26, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Wilmington, NC (United States)

Facility

Other inspections at this facility

  • 1259644 (VAI Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1137604 (NAI Thu Feb 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1101779 (NAI Fri Aug 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1084710 (NAI Thu Mar 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1080667 (NAI Tue Jan 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
135821 CFR 211.100(b)SOPs not followed / documented
145021 CFR 211.113(a)Procedures for non-sterile drug products