Overview
- 2 public-safe observations are available for this inspection.
- 2 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.
28 May 2026
ISO 13485:2016 Clause 7.3.7
Design and development validation not complete prior to release of product
Cited by Maryam Tabatabaie
28 May 2026
ISO 13485:2016 Clause 7.5.6
Process for production and service provision not validated
Cited by Maryam Tabatabaie
Inspected site
ADArjo Dominican RepublicItabo, Haina, Dominican Republic (the)
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.3.7 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 2 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