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1277045

Omega Biological Laboratories Inc. — FEI 3002864704

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 31, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lyndhurst, NJ (United States)

Facility

Other inspections at this facility

  • 1071303 (VAI Wed Nov 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884889 (NAI Wed Jun 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779782 (VAI Mon May 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 730031 (VAI Wed Jun 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 672552 (VAI Fri Jul 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
360321 CFR 211.160(b)Scientifically sound laboratory controls