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FDA Inspection
•Children's Healthcare of Atlanta•October 31, 2017

Children's Healthcare of Atlanta – FDA Inspection, Oct 31, 2017

Record Details

This FDA Inspection record concerns Children's Healthcare of Atlanta, with an inspection on October 31, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Children's Healthcare of Atlanta
Inspection Date
October 31, 2017
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Brentley S. Pittman (Investigator)
View Company Profile

ID · f29c39ef-0231-46fb-9ea6-29d0913ae4e1

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1030727
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 600.14(c)When to report

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Children's Healthcare of Atlanta

6
DateClassificationOfficeProject area
May 23, 2025NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 10, 2020NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 13, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 15, 2013NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
March 3, 2011NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 6 other inspections on the company page
Other documents for Children's Healthcare of Atlanta
  • FDA Inspection 1271213 - 2025-05-23
  • FDA Inspection 1120702 - 2020-02-10
  • FDA Inspection 925841 - 2015-05-13
  • FDA Inspection 818511 - 2013-02-15
  • FDA Inspection 713239 - 2011-03-03

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