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1036150

Optikem International, Inc. — FEI 1720129

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 11, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Denver, CO (United States)

Facility

Other inspections at this facility

  • 1231534 (OAI Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1174263 (VAI Mon Jul 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015917 (VAI Wed May 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 650470 (NAI Thu Mar 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
181021 CFR 211.160(a)Lab controls established, including changes
197521 CFR 211.182Written records kept in individual logs
200921 CFR 211.188Prepared for each batch, include complete information
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation