Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
DIDSRV, IncBudd Lake, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 483 report
Get the verbatim text of all 6 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere