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1193101

Sentara Infusion Services — FEI 3011627411

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 16, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chesapeake, VA (United States)

Facility

Other inspections at this facility

  • 1064475 (VAI Mon Aug 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 936197 (OAI Thu Jul 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
18937FDCA 501(a)(2)(A)Beta-lactam drugs, inadequate sanitation
18944FDCA 501(a)(2)(A)Exposure of personnel in aspectic processing
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
18954FDCA 501(a)(2)(A)Actionable microbial contamination, adjacent area
18956FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
18970FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
18973FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area