Acorn Stairlifts, Inc – FDA Inspection, Nov 12, 2014

Record Details

This FDA Inspection record concerns Acorn Stairlifts, Inc, with an inspection on November 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Acorn Stairlifts, Inc
Inspection Date: November 12, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · b19ffee9-5510-44ce-8b7a-f4e4ed0a8545

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 903190
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.170(a)Lack of or inadequate instructions
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.200(a)Servicing - Lack of or inadequate procedures

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Other FDA inspections of Acorn Stairlifts, Inc

Date	Classification	Office	Project area
December 3, 2025	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
June 5, 2025	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
May 12, 2023	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
July 16, 2021	VAI	Center for Devices and Radiological Health	Compliance: Devices
September 4, 2018	VAI	Center for Devices and Radiological Health	Compliance: Devices