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1029869

Safecor Health, LLC — FEI 1218914

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 19, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Woburn, MA (United States)

Facility

Other inspections at this facility

  • 1288964 (VAI Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1242121 (VAI Mon Jun 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1200011 (OAI Thu Mar 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947114 (OAI Tue Oct 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 713229 (VAI Mon Mar 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
194321 CFR 211.180(e)(1)Review of representative number of batches
354721 CFR 211.46(b)Equipment for Environmental Control
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
361621 CFR 211.165(d)Acceptance criteria for sampling & testing
438721 CFR 211.198(a)Reporting of adverse drug experience to FDA