Overview
- 13 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-09-23.
At a glance
Inspections
13
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Sep 2021 – 23 Sep 2021 | Medical Devices & Rad Health | Clean | |
| 7 Jun 2017 – 14 Jun 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Sep 2015 – 10 Sep 2015 | Medical Devices & Rad Health | Clean | |
| 2 Sep 2015 – 4 Sep 2015 | Medical Devices & Rad Health | Clean | |
| 13 Jan 2015 – 12 Feb 2015 | Medical Devices & Rad Health | WL | On file |
| 19 Mar 2012 | Not recorded | Clean | |
| 9 Nov 2009 | Not recorded | 483 | View 483 → |
| 5 Jun 2008 | Not recorded | 483 | On file |
| 19 Dec 2006 | Not recorded | Clean | |
| 23 May 2003 | Not recorded | Clean | |
| 30 May 2001 | Not recorded | Clean | |
| 31 Aug 2000 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Nov 2009
21 CFR 211.115(a)
Reprocessing procedures lack steps to be taken
Cited by Matthew R Noonan, Michael J Nerz, Jeen S Min
Investigators
FDA investigators tied to this site in the record.
Edwin L Hobbs3 insp.
Brian S Keefer2 insp.
Raffi B Papazian2 insp.
Michael J Nerz2 insp.
Jacob M Dyer1 insp.
Thomas E Friel1 insp.
Kendra L Brooks1 insp.
Matthew R Noonan1 insp.
Jeen S Min1 insp.
Julianne C Mccullough1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medical Components, Inc dba MedComp'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