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1200011

Safecor Health, LLC — FEI 1218914

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 16, 2023
Fiscal Year
2023
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))
  • 1029869 (VAI Thu Oct 19 2017 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
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
163621 CFR 211.130(e)Packaging line inspection before use
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
202721 CFR 211.192Investigations of discrepancies, failures
2129721 CFR 211.186(a)Master production and control records, procedure
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings