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998960

H & A Walters Fulfillment Center LLC. — FEI 3013164929

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 20, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gainesville, GA (United States)

Facility

Other inspections at this facility

  • 1119221 (VAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1082692 (OAI Fri Mar 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
145021 CFR 211.113(a)Procedures for non-sterile drug products
200921 CFR 211.188Prepared for each batch, include complete information
357321 CFR 211.101(b)Measured components for manufacturing
358521 CFR 211.110(a)Control procedures to monitor and validate performance
900121 CFR 211.22(a)Lack of quality control unit