FDA Inspection
DSRV, IncDSRV, Inc – FDA Inspection, Mar 27, 2026
Record Details
This FDA Inspection record concerns DSRV, Inc, with an inspection on March 27, 2026, issued by the New Jersey District Office, covering medical devices & rad health.
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ID · a227fb5c-7318-4ce2-96e2-09918b4c9a3c
Inspection Facts
- Inspection number
- 1309570
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
6- ISO 13485:2016 Clause 7.4.3Impact of changes to purchased product not determined
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 7.3.2Design and development of product not planned and controlled
- ISO 13485:2016 Clause 7.3.3Design and development inputs do not include all requirements
- ISO 13485:2016 Clause 7.6Previous measuring results not assessed and recorded when necessary
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Other FDA inspections of DSRV, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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