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1269575

GRAM Laboratories, Inc. — FEI 3002657995

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 8, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

  • 1068237 (NAI Wed Sep 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941212 (VAI Fri Sep 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 805255 (NAI Tue Oct 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 733887 (NAI Wed Jul 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 645522 (NAI Tue Feb 16 2010 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
440221 CFR 211.192Written record of investigation incomplete