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672552

Omega Biological Laboratories Inc. — FEI 3002864704

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 9, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lyndhurst, NJ (United States)

Facility

Other inspections at this facility

  • 1277045 (VAI Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
117721 CFR 211.63Equipment Design, Size and Location
181021 CFR 211.160(a)Lab controls established, including changes
203421 CFR 211.194(d)Laboratory equipment calibration records