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FDA Inspection
•Children's Hospital Los Angeles•June 14, 2011

Children's Hospital Los Angeles – FDA Inspection, Jun 14, 2011

Record Details

This FDA Inspection record concerns Children's Hospital Los Angeles, with an inspection on June 14, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Children's Hospital Los Angeles
Inspection Date
June 14, 2011
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · bdf5b191-c130-47f6-8448-f642816523ea

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
731995
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

4
  1. 21 CFR 606.100(c)Record review prior to release
  2. 21 CFR 640.3(a)(1)Donor suitability procedures not followed
  3. 21 CFR 606.160(a)(1)Person performing, test results, interpretation
  4. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Children's Hospital Los Angeles

7
DateClassificationOfficeProject area
September 22, 2025Not classifiedLos Angeles District Office
October 9, 2024NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
April 24, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 18, 2017VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 22, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 7 other inspections on the company page
Other documents for Children's Hospital Los Angeles
  • FDA Inspection 1291838 - 2025-09-22
  • FDA Inspection 1251820 - 2024-10-09
  • FDA Inspection 1090959 - 2019-04-24
  • FDA Inspection 1018168 - 2017-05-18
  • FDA Inspection 943550 - 2015-09-22

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