FDA Inspection
King Brand Healthcare Products Ltd.King Brand Healthcare Products Ltd. – FDA Inspection, Jul 24, 2026
Record Details
This FDA Inspection record concerns King Brand Healthcare Products Ltd., with an inspection on July 24, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4de8e96b-f06c-4aef-8b69-5bb76e96afb8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1328000
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- ISO 13485:2016 Clause 7.3.10Design and development files not maintained
- ISO 13485:2016 Clause 7.5.8No documented system to assign unique device identification (UDI)
- ISO 13485:2016 Clause 6.2(a)Maintenance records not maintained
- ISO 13485:2016 Clause 7.3.10Design and development validation not performed as planned
- ISO 13485:2016 Clause 4.1.5External party controls do not include written quality agreements
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
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Other FDA inspections of King Brand Healthcare Products Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 31, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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