Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-01.
At a glance
Inspections
10
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Nov 2023 – 1 Dec 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Jun 2021 – 22 Jun 2021 | Medical Devices & Rad Health | Clean | |
| 4 Feb 2015 – 9 Mar 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Mar 2013 – 16 Apr 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Jan 2010 | Not recorded | Clean | |
| 20 Jul 2009 | Not recorded | Clean | |
| 19 Jun 2009 | Not recorded | 483 | On file |
| 12 Jul 2007 | Not recorded | Clean | |
| 9 Feb 2005 | Not recorded | Clean | |
| 1 Sep 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Dec 2023
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Frank J Marciniak, Shirley S Wen, Matthew W Kyle
9 Mar 2015
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Li Li
16 Apr 2013
21 CFR 820.70(b)
Production and Process Change Procedures, lack of or Inad.
Cited by Li Li, Miguel G Manzano
Investigators
FDA investigators tied to this site in the record.
Li Li3 insp.
Robert G Ruff3 insp.
Matthew W Kyle2 insp.
Frank J Marciniak1 insp.
Shirley S Wen1 insp.
Melissa A Zuppe1 insp.
Miguel G Manzano1 insp.
Deborah B Nixon1 insp.
Dennis E Guilfoyle1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Howmedica Osteonics Corp.'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