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FDA Inspection
•UNC Healthcare/Fertility•December 16, 2014

FDA Inspection 907102 - UNC Healthcare/Fertility - December 16, 2014

Record Details

This FDA Inspection record concerns UNC Healthcare/Fertility, with an inspection on December 16, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
UNC Healthcare/Fertility
Inspection Date
December 16, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · ecff4100-aa70-4a21-92c5-eaf161aa1245

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
907102
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

1
  1. 21 CFR 1271.85(b)(1)Cell-associated CD

Full citation text and observation details available on the Dashboard.

Other FDA inspections of UNC Healthcare/Fertility

6
DateClassificationOfficeProject area
March 19, 2024NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 20, 2022NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
November 14, 2018NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
November 7, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
February 6, 2013NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 6 other inspections on the company page
Other documents for UNC Healthcare/Fertility
  • FDA Inspection 1234691 - 2024-03-19
  • FDA Inspection 1175131 - 2022-07-20
  • FDA Inspection 1072636 - 2018-11-14
  • FDA Inspection 992501 - 2016-11-07
  • FDA Inspection 819290 - 2013-02-06

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