Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-08-31.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Aug 2017 – 31 Aug 2017 | Medical Devices & Rad Health | 483 | On file |
| 1 Apr 2014 – 3 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Jul 2011 | Not recorded | Clean | |
| 2 May 2010 | Not recorded | 483 | View 483 → |
| 27 Nov 2005 | Not recorded | Clean | |
| 5 Aug 2004 | Not recorded | Clean | |
| 17 Jul 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Apr 2014
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Catherine J Laufmann
3 Apr 2014
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Catherine J Laufmann
3 Apr 2014
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Catherine J Laufmann
3 Apr 2014
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Catherine J Laufmann
3 Apr 2014
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Catherine J Laufmann
Investigators
FDA investigators tied to this site in the record.
Wanda B Coats1 insp.
Lori S Lawless1 insp.
Catherine J Laufmann1 insp.
Joseph A Morkunas1 insp.
Rodney D Combs1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | 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 |
Full site report
Get the verbatim findings behind Mediplast Israel Ltd.'s 3 Form 483s
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