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902595

SigmaPharm Laboratories LLC — FEI 3005444934

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 19, 2014
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bensalem, PA (United States)

Facility

Other inspections at this facility

  • 1297588 (VAI Wed Dec 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1200965 (NAI Mon Feb 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1158426 (NAI Tue Dec 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056891 (NAI Wed Jun 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015810 (VAI Mon Jun 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
256921 CFR 211.198(b)Maintenance of Complaint File
358521 CFR 211.110(a)Control procedures to monitor and validate performance
361621 CFR 211.165(d)Acceptance criteria for sampling & testing
363221 CFR 211.170(b)Annual visual exams of drug products