Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-09-14.
At a glance
Inspections
7
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Aug 2017 – 14 Sep 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 May 2017 – 12 May 2017 | Medical Devices & Rad Health | 483 | On file |
| 13 Apr 2015 – 24 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Aug 2013 – 30 Aug 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Sep 2011 | Not recorded | Clean | |
| 23 Jul 2008 | Not recorded | Clean | |
| 17 Mar 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Sep 2017
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Claudette D Brooks
14 Sep 2017
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Claudette D Brooks
Investigators
FDA investigators tied to this site in the record.
Claudette D Brooks1 insp.
MDSAP WilliamsA1 insp.
Dawn M Braswell1 insp.
Gamal A Norton1 insp.
Babatunde D Babalola1 insp.
Patricia F Hudson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | 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 Ethicon, Inc.'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