FDA Inspection 1328000 — King Brand Healthcare Products
The FDA completed an inspection of King Brand Healthcare Products on Jul 24, 2026 in Bellingham, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bellingham, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23026 | ISO 13485:2016 Clause 4.1.5 | External party controls do not include written quality agreements |
| 23078 | ISO 13485:2016 Clause 6.3 | Maintenance records not maintained |
| 23119 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not performed as planned |
| 23136 | ISO 13485:2016 Clause 7.3.10 | Design and development files not maintained |
| 23182 | ISO 13485:2016 Clause 7.5.8 | No documented system to assign unique device identification (UDI) |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |