Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-08-28.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Aug 2017 – 28 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 30 Mar 2014 – 31 Mar 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Jul 2011 | Not recorded | Clean | |
| 9 Jun 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Mar 2014
21 CFR 820.30(d)
Design output - Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dorothy W Lee
31 Mar 2014
21 CFR 820.30(e)
Design review - Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dorothy W Lee
31 Mar 2014
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dorothy W Lee
31 Mar 2014
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Catherine J Laufmann, Dorothy W Lee
31 Mar 2014
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Catherine J Laufmann, Dorothy W Lee
Investigators
FDA investigators tied to this site in the record.
Wanda B Coats1 insp.
Lori S Lawless1 insp.
Catherine J Laufmann1 insp.
Dorothy W Lee1 insp.
Edward J Janik1 insp.
James M Kewley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medinol Ltd.'s 2 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