Bieffe Medital SpA – FDA Inspection, Oct 16, 2009

Record Details

This FDA Inspection record concerns Bieffe Medital SpA, with an inspection on October 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Bieffe Medital SpA
Inspection Date: October 16, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 3944e3e4-a9ae-4efc-a936-e42684da688a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 621498
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.100(a)(2)Investigation
21 CFR 820.100(a)(5)Changes to correct/prevent quality problems
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.30(j)Design history file

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Other FDA inspections of Bieffe Medital SpA

Date	Classification	Office	Project area
November 17, 2023	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
June 28, 2019	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
September 28, 2018	Not classified	Office of Inspections and Investigations
May 29, 2018	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
September 22, 2015	NAI	Center for Drug Evaluation and Research	Drug Quality Assurance