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638764

Surgi-Care, Inc. — FEI 3003435341

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 14, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Waltham, MA (United States)

Facility

Other inspections at this facility

  • 1120374 (NAI Mon Feb 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 997637 (VAI Thu Jan 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920502 (NAI Tue Mar 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 828785 (VAI Thu Apr 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1231121 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
1232221 CFR 1271.160(b)(4)Training of personnel
1232321 CFR 1271.160(b)(5)Monitoring systems
1243121 CFR 1271.265(e)Procedures and release criteria
1243621 CFR 1271.270(a)Accurate, indelible, legible