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FDA Inspection
•Southern Tissue Center•June 3, 2016

Southern Tissue Center – FDA Inspection, Jun 3, 2016

Record Details

This FDA Inspection record concerns Southern Tissue Center, with an inspection on June 3, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Southern Tissue Center
Inspection Date
June 3, 2016
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · ed7525f7-4a34-43b4-8aca-3cebcdd3bf69

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
980031
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

4
  1. 21 CFR 1271.195(a)Adequate control, proper conditions
  2. 21 CFR 1271.250(c)All labeling requirements met
  3. 21 CFR 1271.230(a)Process validation procedures
  4. 21 CFR 1271.230(b)Reduced risk representation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Southern Tissue Center

1
DateClassificationOfficeProject area
December 12, 2012NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Southern Tissue Center
  • FDA Inspection 812540 - 2012-12-12

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