Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-06.
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 |
|---|---|---|---|
| 30 Apr 2026 – 6 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Jun 2022 – 8 Jun 2022 | Medical Devices & Rad Health | 483 | On file |
| 2 Mar 2017 – 13 Mar 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Jul 2010 | Not recorded | 483 | View 483 → |
| 8 Jul 2009 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 May 2026
21 CFR 830.300(a)
Devices subject to device identification GUDID data submission requirements.
Cited by Laureen M Geniusz
6 May 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Laureen M Geniusz
6 May 2026
ISO 13485:2016 Clause 7.5.6
Procedures for validation of processes not documented
Cited by Laureen M Geniusz
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 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 830.300(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | 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 7.5.6 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Marlen Manufacturing & Development Co.'s 5 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