Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2016-02-25.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Feb 2016 – 25 Feb 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Jun 2015 – 25 Jun 2015 | Medical Devices & Rad Health | Clean | |
| 18 Mar 2014 – 27 Mar 2014 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Feb 2016
21 CFR 820.72(a)
Equipment control activity documentation
Cited by Gregson A Joseph, Arie Menachem
25 Feb 2016
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Gregson A Joseph, Arie Menachem
25 Feb 2016
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Gregson A Joseph, Arie Menachem
Investigators
FDA investigators tied to this site in the record.
Gregson A Joseph1 insp.
Arie Menachem1 insp.
Shaquenta Y Perkins1 insp.
Lori J Silverstein1 insp.
Richard J Tucker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind B.Y. Medimor Ltd's 1 Form 483
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