Abbott Medical – FDA Inspection, Feb 17, 2017

Record Details

This FDA Inspection record concerns Abbott Medical, with an inspection on February 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: Abbott Medical
Inspection Date: February 17, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
People: Alford R. Taylor (FDA Associated Person)
Leonard H. Lavi (FDA Associated Person)

View Company Profile

ID · c4a66a8c-7793-4dab-b898-69638bb89c7b

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1000696
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
21 CFR 820.30(f)Design verification - output does not meet input requirement
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product control
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Abbott Medical

Date	Classification	Office	Project area
June 28, 2023	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
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
March 24, 2016	NAI	Center for Devices and Radiological Health	Compliance: Devices