Abbott Medical – FDA Inspection, Jul 8, 2009

Record Details

This FDA Inspection record concerns Abbott Medical, with an inspection on July 8, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Abbott Medical
Inspection Date: July 8, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 1204c9d7-1c1f-493a-83f6-3c6b4754c7d5

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 602308
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 803.50(b)(1)Reporting Information Reasonably Known
21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.30(e)Design reviews performed following schedule
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.250(b)Reviewed for adequacy
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(f)Design verification - unresolved discrepancies

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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
February 17, 2017	OAI	Center for Devices and Radiological Health	Compliance: Devices