Home / Inspections / 839741

839741

Bio Tech Med Corp. — FEI 3007946244

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 2, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
San German, PR (United States)

Facility

Other inspections at this facility

  • 1117665 (NAI Fri Jan 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1037952 (NAI Thu Dec 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947311 (NAI Tue Oct 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 635042 (NAI Fri Dec 11 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1233821 CFR 1271.180(b)Review and approval-responsible person
1241621 CFR 1271.260(e)Storage temperatures recorded, maintained
1243121 CFR 1271.265(e)Procedures and release criteria