Home / Inspections / 1034828

1034828

Intrathecal Compounding Specialists, LLC — FEI 3006372310

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 17, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Scott, LA (United States)

Facility

Other inspections at this facility

  • 1149221 (VAI Thu Aug 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081945 (OAI Thu Feb 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
18936FDCA 501(a)(2)(A)Non-microbial contamination, production area
18939FDCA 501(a)(2)(A)Highly potent drugs, prevention of cross-contamination
18941FDCA 501(a)(2)(A)Improper gowning, contamination
18944FDCA 501(a)(2)(A)Exposure of personnel in aspectic processing
18947FDCA 501(a)(2)(A)Personnel in aseptic processing, cleanroom gowning
18951FDCA 501(a)(2)(A)Personnel contact outside ISO 5 area
18953FDCA 501(a)(2)(A)Actionable microbial contamination, ISO 5 area
18956FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
18973FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area
21284FDCA 501(a)(2)(A)Disinfectant contact time