Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-10-01.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Sep 2020 – 1 Oct 2020 | Medical Devices & Rad Health | Clean | |
| 13 Jun 2017 – 20 Jul 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Oct 2015 – 17 Nov 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Apr 2014 – 11 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Aug 2013 – 16 Aug 2013 | Medical Devices & Rad Health | Clean | |
| 14 Mar 2013 – 17 May 2013 | Medical Devices & Rad Health | 483 | On file |
| 22 Jun 2012 | Not recorded | 483 | View 483 → |
| 27 Feb 2009 | Not recorded | Clean | |
| 23 Feb 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Jul 2017
21 CFR 820.100(b)
Documentation
Cited by Adaliz Santaliz-Cruz, Phillip M Pontikos, Bleta Vuniqi
20 Jul 2017
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Adaliz Santaliz-Cruz, Phillip M Pontikos, Bleta Vuniqi
20 Jul 2017
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Adaliz Santaliz-Cruz, Phillip M Pontikos, Bleta Vuniqi
17 Nov 2015
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Adaliz Santaliz-Cruz, Laiza V Garcia, Kimberly Lewandowski-Walker
17 Nov 2015
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Adaliz Santaliz-Cruz, Laiza V Garcia, Kimberly Lewandowski-Walker
Investigators
FDA investigators tied to this site in the record.
Laiza V Garcia5 insp.
Adaliz Santaliz-Cruz3 insp.
Wanda J Torres2 insp.
Monica C Burgos Garcia1 insp.
Phillip M Pontikos1 insp.
Bleta Vuniqi1 insp.
Kimberly Lewandowski-Walker1 insp.
Karl D Hezel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | 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 Zimmer Manufacturing B.V.'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