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698924

Bullet Line LLC — FEI 3005625923

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 6, 2010
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Florence, KY (United States)

Facility

Other inspections at this facility

  • 1171585 (VAI Fri Jun 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1021664 (VAI Tue Aug 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 768620 (NAI Wed Feb 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 763587 (VAI Mon Nov 14 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 698433 (VAI Wed Aug 04 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
176721 CFR 211.137(a)Expiration date lacking
185221 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
191421 CFR 211.166(a)Lack of written stability program
363021 CFR 211.170(b)Drug product reserve containers