Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-26.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Feb 2026 – 26 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Feb 2023 – 16 Feb 2023 | Medical Devices & Rad Health | 483 | On file |
| 6 Nov 2017 – 9 Nov 2017 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Feb 2026
ISO 13485:2016 Clause 4.2.3
Medical device file not established and maintained
Cited by Matthew W Kyle
26 Feb 2026
ISO 13485:2016 Clause 5.5.1
Management responsibilities and authorities not documented
Cited by Matthew W Kyle
26 Feb 2026
ISO 13485:2016 Clause 7.3.1
Design and development procedures not documented
Cited by Matthew W Kyle
26 Feb 2026
ISO 13485:2016 Clause 7.5.11
Procedures for preserving the conformity of product not documented
Cited by Matthew W Kyle
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 803.17(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.2.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.5.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.11 | 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 7.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Me Luna GmbH's 3 Form 483s
Source PDFs, 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