Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-27.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Feb 2026 – 27 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Aug 2012 | Not recorded | 483 | View 483 → |
| 22 Sep 2008 | Not recorded | 483 | On file |
| 8 Sep 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Mar 2026
ISO 13485:2016 Clause 7.3.2
Design and development of product not planned and controlled
Cited by Monica L Gutierrez
27 Mar 2026
ISO 13485:2016 Clause 7.3.3
Design and development inputs do not include all requirements
Cited by Monica L Gutierrez
27 Mar 2026
ISO 13485:2016 Clause 7.4.3
Impact of changes to purchased product not determined
Cited by Monica L Gutierrez
27 Mar 2026
ISO 13485:2016 Clause 7.6
Previous measuring results not assessed and recorded when necessary
Cited by Monica L Gutierrez
27 Mar 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling records not maintained
Cited by Monica L Gutierrez
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind DSRV, Inc's 3 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat