FDA Inspection
Bruno Independent Living Aids, Inc.Bruno Independent Living Aids, Inc. – FDA Inspection, Aug 12, 2021
Record Details
This FDA Inspection record concerns Bruno Independent Living Aids, Inc., with an inspection on August 12, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 12, 2021
- Product Type
- Devices
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ID · 9833614e-61f8-4e19-bf66-75b6ceed1848
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1148890
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.200(d)Service reports
Showing 10 of 13 citations.
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Other FDA inspections of Bruno Independent Living Aids, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 20, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 8, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bruno Independent Living Aids, Inc.
- FDA Inspection 1229326 - 2024-07-12
- FDA Inspection 811408 - 2012-12-20
- FDA Inspection 650761 - 2010-01-08
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