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933385

COLONIAL DAMES CO LTD — FEI 2011035

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 25, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Commerce, CA (United States)

Facility

Other inspections at this facility

  • 1252829 (NAI Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1232599 (VAI Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1203628 (OAI Wed Apr 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1141007 (OAI Thu Apr 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773333 (VAI Tue Mar 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
119421 CFR 211.42(c)Defined areas of adequate size for operations
145021 CFR 211.113(a)Procedures for non-sterile drug products
181021 CFR 211.160(a)Lab controls established, including changes
192221 CFR 211.166(a)(4)Testing in same container - closure system
202721 CFR 211.192Investigations of discrepancies, failures
354721 CFR 211.46(b)Equipment for Environmental Control
360221 CFR 211.160(a)Deviations from laboratory control requirements
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
439121 CFR 211.180(e)(2)Items to cover on annual reviews