FDA Inspection 1327668 — Robin Industries, Inc.
The FDA completed an inspection of Robin Industries, Inc. on Jul 24, 2026 in Millersburg, OH. 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
- Compliance: Devices
- Location
- Millersburg, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23038 | ISO 13485:2016 Clause 4.2.4 | Lack of document control |
| 23077 | ISO 13485:2016 Clause 6.3 | Requirements for infrastructure maintenance activities not documented |
| 23080 | ISO 13485:2016 Clause 6.4.1 | Work environment requirements and procedures not documented |
| 23085 | ISO 13485:2016 Clause 7.1 | Processes needed for product realization not planned and developed |
| 23209 | ISO 13485:2016 Clause 8.1 | Methods for monitoring, measurement, analysis, and improvement not determined |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |