FDA Inspection 1322442 — Arrowhead DE LLC
The FDA completed an inspection of Arrowhead DE LLC on Jun 17, 2026 in Peachtree City, GA. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 17, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Peachtree City, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23142 | ISO 13485:2016 Clause 7.4.1 | Supplier performance not monitored |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |
| 23227 | ISO 13485:2016 Clause 8.2.5 | Suitable methods for monitoring and measuring QMS processes not applied |
| 23234 | ISO 13485:2016 Clause 8.2.6 | Product release and delivery proceeded prior to planned agreements completed |
| 23245 | ISO 13485:2016 Clause 8.3.4 | Rework not performed according to documented procedures |