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716447

Beutlich Pharmaceuticals LLC — FEI 1413399

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 22, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bunnell, FL (United States)

Facility

Other inspections at this facility

  • 1279681 (VAI Wed Aug 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1069715 (VAI Wed Oct 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991891 (NAI Fri Nov 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946582 (NAI Thu Oct 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773041 (NAI Fri Mar 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310421 CFR 820.30(j)Design history file
313021 CFR 820.100(a)Lack of or inadequate procedures
369621 CFR 820.100(b)Documentation
8938FDCA 760(c)(1)Timing of AE report submission (non-RX drugs)