Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-16.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2026 – 16 Apr 2026 | Medical Devices & Rad Health | 483 | On file |
| 22 Oct 2018 – 25 Oct 2018 | Medical Devices & Rad Health | 483 | On file |
| 16 May 2016 – 20 May 2016 | Medical Devices & Rad Health | 483 | On file |
| 4 Nov 2013 – 7 Nov 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Jun 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Nov 2013
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Dawn M Braswell
Investigators
FDA investigators tied to this site in the record.
Maryam Tabatabaie1 insp.
Dianiris C Ayala1 insp.
Kelvin Cheung1 insp.
Dawn M Braswell1 insp.
Kirtida Patel1 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 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind AMBU Limited's 5 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