Abbott Medical – FDA Inspection, Jun 28, 2023

Record Details

This FDA Inspection record concerns Abbott Medical, with an inspection on June 28, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company: Abbott Medical
Inspection Date: June 28, 2023
Product Type: Devices
Office: Center for Devices and Radiological Health
People: Janet Pulver (FDA Associated Person)
Kenya Destin

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ID · 70033da4-bbd1-4ce1-aeae-09ad6472d6a3

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1209394
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 806.10(a)(1)Report of risk to health
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures

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Other FDA inspections of Abbott Medical

Date	Classification	Office	Project area
January 17, 2020	NAI	Center for Devices and Radiological Health	Bioresearch Monitoring
August 2, 2019	NAI	Center for Devices and Radiological Health	Bioresearch Monitoring
September 20, 2018	Not classified	Los Angeles District Office
February 17, 2017	OAI	Center for Devices and Radiological Health	Compliance: Devices
March 24, 2016	NAI	Center for Devices and Radiological Health	Compliance: Devices