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1164181

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding — FEI 3014229024

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 10, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Richardson, TX (United States)

Facility

Other inspections at this facility

  • 1280796 (VAI Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
18939FDCA 501(a)(2)(A)Highly potent drugs, prevention of cross-contamination
18954FDCA 501(a)(2)(A)Actionable microbial contamination, adjacent area
18966FDCA 501(a)(2)(A)Non-sterilized and non-depyrogenated, sterile drug
18968FDCA 501(a)(2)(A)Inadequate filter, final product sterilization
18973FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area
21377FDCA 501(a)(2)(A)Use of non-pharmaceutical grade components