FDA Inspection 1298000 — Solomon Park Research Laboratories, Inc.
The FDA completed an inspection of Solomon Park Research Laboratories, Inc. on January 8, 2026 in Burien, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 8, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Burien, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |