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1158271

Calvin Scott & Company, Inc. — FEI 1619076

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 2, 2021
Fiscal Year
2022
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))
  • 1144336 (VAI Fri Jun 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120650 (OAI Thu Mar 12 2020 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
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
154021 CFR 211.125(a)Strict control not exercised over labeling issued
163721 CFR 211.130(e)Packaging line inspection after use
187621 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
197521 CFR 211.182Written records kept in individual logs
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
439121 CFR 211.180(e)(2)Items to cover on annual reviews