Nicklaus Children's Hospital, Miami, FL – FDA Inspections

Inspection records and compliance data for Nicklaus Children's Hospital in Miami, Florida. 6 FDA inspections on record, last inspected November 06, 2024.

Company Profile

This profile covers Nicklaus Children's Hospital based in Miami, Florida, United States.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 1
NAI: 4
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected May 20, 2011. Last inspected November 6, 2024.

Most cited issue areas

Adverse reaction - Disposition of Reports1 inspection
Adverse Reaction- Reports of Investigations1 inspection
Biological product deviation report1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
November 6, 2024	Not classified	Biologics	1253722
February 23, 2023	NAI	Biologics · Vaccines and Allergenic Products	1198477
August 7, 2019	NAI	Biologics · Blood and Blood Products	1102551
August 3, 2016	VAI	Biologics · Blood and Blood Products	984201
May 22, 2014	NAI	Biologics · Blood and Blood Products	887839
May 20, 2011	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	727131

FDA documents

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

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