Cook Children's Medical Center (CCMC), Fort Worth, TX – FDA Inspections

Inspection records and compliance data for Cook Children's Medical Center (CCMC) in Fort Worth, Texas. 7 FDA inspections on record, last inspected January 08, 2025.

Company Profile

This profile covers Cook Children's Medical Center (CCMC) based in Fort Worth, Texas, United States.

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 1
NAI: 5
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected June 9, 2010. Last inspected January 8, 2025.

Most cited issue areas

Concurrent documentation1 inspection
Equipment calibration frequency1 inspection
Establish, maintain and follow manufacturing SOPs1 inspection

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
January 8, 2025	Not classified	Biologics	1258391
February 28, 2020	NAI	Biologics · Vaccines and Allergenic Products	1121119
February 15, 2018	NAI	Biologics · Blood and Blood Products	1050595
March 1, 2016	NAI	Biologics · Blood and Blood Products	963417
June 9, 2014	NAI	Biologics · Blood and Blood Products	882366
September 27, 2012	VAI	Biologics · Blood and Blood Products	800812
June 9, 2010	NAI	Biologics · Blood and Blood Products	666653

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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