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1120650

Calvin Scott & Company, Inc. — FEI 1619076

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 12, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Albuquerque, NM (United States)

Facility

Other inspections at this facility

  • 1208469 (VAI Mon Jun 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1158271 (OAI Thu Dec 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1144336 (VAI Fri Jun 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099743 (VAI Fri Aug 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884815 (NAI Wed Jun 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
116521 CFR 211.28(d)Excluding Employees with Illness, Lesions
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
155021 CFR 211.125(f)Procedures Written and Followed
163621 CFR 211.130(e)Packaging line inspection before use
172421 CFR 211.134(b)Representative samples after completion
191421 CFR 211.166(a)Lack of written stability program
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
900121 CFR 211.22(a)Lack of quality control unit