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756094

Bioserv Corporation — FEI 2027352

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 7, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 1195989 (NAI Thu Jan 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022355 (NAI Mon Jul 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 863803 (NAI Thu Jan 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 804269 (NAI Wed Oct 24 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 656899 (NAI Mon Apr 12 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145221 CFR 211.113(b)Validation lacking for sterile drug products
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified