Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-19.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jun 2026 – 19 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Dec 2018 – 13 Dec 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Jul 2016 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Jun 2026
ISO 13485:2016 Clause 7.4.1
Criteria for the evaluation and selection of suppliers not established
Cited by Marlo-Ian M Alintanahin
13 Dec 2018
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by John A Sciacchitano
Investigators
FDA investigators tied to this site in the record.
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 | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Asap Endoscopic Products GmbH's 2 Form 483s
Source PDFs 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