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1098887

Randol Mill Pharmacy — FEI 3010177428

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 6, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Arlington, TX (United States)

Facility

Other inspections at this facility

  • 1170332 (NAI Mon May 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
144821 CFR 211.111Establishment of time limitations
145121 CFR 211.113(b)Procedures for sterile drug products
18938FDCA 501(a)(2)(A)Hazardous drugs, prevention of cross-contamination
18944FDCA 501(a)(2)(A)Exposure of personnel in aspectic processing
18961FDCA 501(a)(2)(A)Air flow quality, higher classified area
18966FDCA 501(a)(2)(A)Non-sterilized and non-depyrogenated, sterile drug
191421 CFR 211.166(a)Lack of written stability program