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972651

Mid-Atlantic Surgical Systems, LLC — FEI 3008847058

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 30, 2016
Fiscal Year
2016
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Carnegie, PA (United States)

Facility

Other inspections at this facility

  • 1173785 (NAI Thu Jun 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066715 (NAI Thu Aug 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866375 (NAI Tue Feb 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 759509 (VAI Wed Dec 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1231121 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
1232421 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
1232621 CFR 1271.160(c)Quality audits performed periodically
1234021 CFR 1271.180(d)Adopted from another organization
1236521 CFR 1271.195(d)Documentation not maintained
1243321 CFR 1271.265(f)Return to inventory--procedures