Home / Inspections / 1120795

1120795

Walfer Corporation dba Wallace Pharmacy — FEI 3016458098

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 16, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Port Charlotte, FL (United States)

Facility

Other inspections at this facility

  • 1171015 (NAI Thu May 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
18933FDCA 501(a)(2)(A)Vermin, production area
18938FDCA 501(a)(2)(A)Hazardous drugs, prevention of cross-contamination
18943FDCA 501(a)(2)(A)Personnel in aseptic processing, non-sterile gloves
18944FDCA 501(a)(2)(A)Exposure of personnel in aspectic processing
18945FDCA 501(a)(2)(A)Aseptic processing outside ISO 5 area
18950FDCA 501(a)(2)(A)Personnel contact on container or closure
18955FDCA 501(a)(2)(A)Ceiling tiles, cleanroom
18956FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
18960FDCA 501(a)(2)(A)Flow of personnel and materials, facility
18962FDCA 501(a)(2)(A)Lack of HEPA filter, sterile product area
18965FDCA 501(a)(2)(A)Sinks, drains in cleanroom of ISO 5 area
18968FDCA 501(a)(2)(A)Inadequate filter, final product sterilization
18970FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
18971FDCA 501(a)(2)(A)No sporicidal agents, cleanroom and ISO 5 area