FDA Inspection 1319304 — Arjo Dominican Republic
The FDA completed an inspection of Arjo Dominican Republic on May 28, 2026 in Itabo, Haina. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 28, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Itabo, Haina (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 23125 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not complete prior to release of product |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |