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1038731

Infusion Partners, LLC — FEI 3013995728

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 26, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Canfield, OH (United States)

Facility

Other inspections at this facility

  • 1153907 (NAI Wed Sep 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
18937FDCA 501(a)(2)(A)Beta-lactam drugs, inadequate sanitation
18941FDCA 501(a)(2)(A)Improper gowning, contamination
18942FDCA 501(a)(2)(A)Personnel habits, contamination
18948FDCA 501(a)(2)(A)Disruption of airflow from personnel movement
18949FDCA 501(a)(2)(A)First pass air blockage, open unit with sterile product
18951FDCA 501(a)(2)(A)Personnel contact outside ISO 5 area
18956FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
18961FDCA 501(a)(2)(A)Air flow quality, higher classified area
18973FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area
21284FDCA 501(a)(2)(A)Disinfectant contact time