FDA Inspection 1326128 — Swami Medical, LLC
The FDA completed an inspection of Swami Medical, LLC on Jul 10, 2026 in Del Mar, CA. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 10, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Del Mar, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23104 | ISO 13485:2016 Clause 7.3.3 | Design and development inputs do not include all requirements |
| 23176 | ISO 13485:2016 Clause 7.5.7 | Processes for sterilization and sterile barrier systems not validated |