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1225087

Granules Pharmaceuticals Inc. — FEI 3011585184

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 15, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chantilly, VA (United States)

Facility

Other inspections at this facility

  • 1215034 (NAI Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1175097 (VAI Fri Jul 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035023 (VAI Fri Dec 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
139621 CFR 211.42(c)(2)Rejected Material Area
356521 CFR 211.58Buildings not maintained in good state of repair