FDA Inspection 1302198 — Indilab, Inc.
The FDA completed an inspection of Indilab, Inc. on February 9, 2026 in Franklin Park, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 9, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Franklin Park, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23099 | ISO 13485:2016 Clause 7.3.2 | Design and development of product not planned and controlled |
| 636 | 21 CFR 803.17(b)(2) | Reports and information documentation |