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1060191

Digestive Care Inc — FEI 1000136461

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 27, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bethlehem, PA (United States)

Facility

Other inspections at this facility

  • 1208822 (VAI Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942797 (VAI Fri Sep 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 771288 (VAI Fri Mar 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 666900 (NAI Fri Jun 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 599963 (VAI Wed Jul 22 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
202721 CFR 211.192Investigations of discrepancies, failures
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications