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1235828

Denver Solutions, LLC — FEI 3013438582

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 5, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Englewood, CO (United States)

Facility

Other inspections at this facility

  • 1153931 (VAI Thu Oct 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096795 (VAI Thu Jul 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042272 (VAI Fri Feb 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
145121 CFR 211.113(b)Procedures for sterile drug products
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
22787FDCA 503B(a)(10)(A)Drug product labels, fails to include
22789FDCA 503B(a)(10)(B)Drug product container, fails to include