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752063

Ortho Pros, Inc. — FEI 3006480449

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 21, 2011
Fiscal Year
2012
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Littleton, CO (United States)

Facility

Other inspections at this facility

  • 1280986 (NAI Tue Aug 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083581 (NAI Wed Feb 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 959248 (NAI Tue Feb 23 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 634422 (NAI Mon Dec 14 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1233421 CFR 1271.170(c)Trained or re-trained as necessary
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1241421 CFR 1271.260(d)Corrective actions
1241621 CFR 1271.260(e)Storage temperatures recorded, maintained
1241721 CFR 1271.260(e)Periodic review of temperatures
1242421 CFR 1271.265(c)(1)Release criteria verified, documented
1242921 CFR 1271.265(d)Shipping conditions appropriate
1243221 CFR 1271.265(e)Documentation elements for activities
1244721 CFR 1271.290(b)Establishing a system