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1116917

Ohm Laboratories Inc. — FEI 3004132058

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 5, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
New Brunswick, NJ (United States)

Facility

Other inspections at this facility

  • 1254992 (NAI Thu Oct 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1230728 (NAI Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1192906 (NAI Thu Nov 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1151837 (NAI Mon Aug 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062424 (NAI Fri Aug 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
180921 CFR 211.160(a)Following/documenting laboratory controls
202821 CFR 211.192Extent of discrepancy, failure investigations