Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-18.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jun 2026 – 18 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Feb 2026 – 20 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Jun 2026
ISO 13485:2016 Clause 6.4.2
Requirements for contamination control of sterile devices not documented
Cited by Christopher R Czajka, Alexandria L Capuano, Luis P Torres, Jay-Ar C Bendo
18 Jun 2026
ISO 13485:2016 Clause 7.5.1
Production controls not adequate
Cited by Christopher R Czajka, Alexandria L Capuano, Luis P Torres, Jay-Ar C Bendo
Investigators
FDA investigators tied to this site in the record.
Christopher R Czajka1 insp.
Alexandria L Capuano1 insp.
Luis P Torres1 insp.
Jay-Ar C Bendo1 insp.
Lan T Tran1 insp.
Farwa Z Razvi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.4.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MedAlliance, 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