FDA Inspection 1321406 — Saris and Things, Inc.
The FDA completed an inspection of Saris and Things, Inc. on June 10, 2026 in Plainfield, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 10, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Plainfield, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |