FDA Inspection 1242650 — Seattle Bioceramics, Inc.
The FDA completed an inspection of Seattle Bioceramics, Inc. on Jul 1, 2024 in Kent, 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 1, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kent, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |