Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-09.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Apr 2026 – 9 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Aug 2023 – 7 Sep 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Apr 2019 – 13 May 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Feb 2012 | Not recorded | 483 | On file |
| 26 Feb 2009 | Not recorded | Clean | |
| 17 Oct 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Apr 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Elizabeth A Krolczyk
7 Sep 2023
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Jocelyn C Turner
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 820.184 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medco Manufacturing, LLC's 4 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