Home / Inspections / 767433

767433

New England Cryogenic Center, Inc. — FEI 3002733251

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 6, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Marlborough, MA (United States)

Facility

Other inspections at this facility

  • 1281063 (NAI Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1158602 (NAI Wed Nov 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074514 (NAI Mon Nov 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 994774 (NAI Wed Dec 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895389 (NAI Wed Sep 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1232421 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
1233621 CFR 1271.180(a)Procedures to meet core CTGP
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations