Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-04-23.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Apr 2026 – 23 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Nov 2018 – 19 Nov 2018 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Apr 2026
ISO 13485:2016 Clause 7.3.9
Procedures to control design and development changes not documented
Cited by Yuliana Hernandez-Magana
23 Apr 2026
ISO 13485:2016 Clause 7.4.1
Supplier performance not monitored
Cited by Yuliana Hernandez-Magana
23 Apr 2026
ISO 13485:2016 Clause 7.5.6
Process for production and service provision not validated
Cited by Yuliana Hernandez-Magana
23 Apr 2026
ISO 13485:2016 Clause 8.2.1
Information gathered in feedback process not used as input into risk management
Cited by Yuliana Hernandez-Magana
23 Apr 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures lack required elements
Cited by Yuliana Hernandez-Magana
Investigators
FDA investigators tied to this site in the record.
Yuliana Hernandez-Magana1 insp.
State Agency1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 1x |
| 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 8.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Astura Medical's 1 Form 483
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