Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-17.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jun 2026 – 17 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Dec 2022 – 7 Dec 2022 | Medical Devices & Rad Health | Clean | |
| 28 Mar 2016 – 30 Mar 2016 | Medical Devices & Rad Health | Clean | |
| 20 Nov 2012 | Not recorded | Clean | |
| 21 Feb 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jun 2026
ISO 13485:2016 Clause 7.5.6
Process for production and service provision not validated
Cited by Melanie W Pishnery
17 Jun 2026
ISO 13485:2016 Clause 8.2.5
Suitable methods for monitoring and measuring QMS processes not applied
Cited by Melanie W Pishnery
17 Jun 2026
ISO 13485:2016 Clause 8.2.6
Product release and delivery proceeded prior to planned agreements completed
Cited by Melanie W Pishnery
17 Jun 2026
ISO 13485:2016 Clause 8.3.4
Rework not performed according to documented procedures
Cited by Melanie W Pishnery
Investigators
FDA investigators tied to this site in the record.
Melanie W Pishnery1 insp.
Javelle P Spann1 insp.
Charvais S Hill1 insp.
Mary A Millner1 insp.
Charvais S Bogan1 insp.
Thomas O Morgan1 insp.
Erica M Katherine1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.5 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.4 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Arrowhead DE LLC's 2 Form 483s
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