FDA Inspection 1323488 — First Source, Inc.
The FDA completed an inspection of First Source, Inc. on June 24, 2026 in Rochester, NY. 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
- June 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rochester, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23130 | ISO 13485:2016 Clause 7.3.9 | Procedures to control design and development changes not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |