FDA Inspection 1309384 — CSA Medical, Inc.
The FDA completed an inspection of CSA Medical, Inc. on March 23, 2026 in Lexington, MA. 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
- March 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lexington, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |