FDA Inspection
Acorn Stairlifts, IncAcorn Stairlifts, Inc – FDA Inspection, Dec 9, 2016
Record Details
This FDA Inspection record concerns Acorn Stairlifts, Inc, with an inspection on December 9, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6d0f62b5-c6ec-413b-9380-8018e25149ef
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 995538
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Acorn Stairlifts, Inc
6| 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 |
Other documents for Acorn Stairlifts, Inc
- FDA Inspection 1294138 - 2025-12-03
- FDA Inspection 1270317 - 2025-06-05
- FDA Inspection 1207741 - 2023-05-12
- FDA Inspection 1147267 - 2021-07-16
- FDA Inspection 1064826 - 2018-09-04
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