Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-09.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2026 – 9 Apr 2026 | Medical Devices & Rad Health | Clean | |
| 8 Nov 2021 | Medical Devices & Rad Health | Clean | |
| 21 Jun 2017 – 26 Jun 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Feb 2013 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jun 2017
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by David J Gasparovich
Investigators
FDA investigators tied to this site in the record.
Chad E Schmear1 insp.
Nicholas Z Lu1 insp.
David J Gasparovich1 insp.
Kimberly Lewandowski-Walker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind AED Battery Exchange LLC's 2 Form 483s
Verbatim observations and 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