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1006683

Cosway Company, Inc. — FEI 3000205953

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 10, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Carson, CA (United States)

Facility

Other inspections at this facility

  • 1250780 (NAI Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1224437 (VAI Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1198266 (VAI Fri Feb 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 840678 (VAI Thu Jul 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754860 (VAI Thu Nov 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
178721 CFR 211.80(a)Procedures To Be in Writing
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
357021 CFR 211.100(a)Approval and review of procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls
434221 CFR 211.142(b)Storage under appropriate conditions