FDA Inspection 1309570 — DSRV, Inc
The FDA completed an inspection of DSRV, Inc on Mar 27, 2026 in Budd Lake, NJ. 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
- Mar 27, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Budd Lake, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23099 | ISO 13485:2016 Clause 7.3.2 | Design and development of product not planned and controlled |
| 23104 | ISO 13485:2016 Clause 7.3.3 | Design and development inputs do not include all requirements |
| 23152 | ISO 13485:2016 Clause 7.4.3 | Impact of changes to purchased product not determined |
| 23201 | ISO 13485:2016 Clause 7.6 | Previous measuring results not assessed and recorded when necessary |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |