Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-03-02.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Feb 2016 – 2 Mar 2016 | Human Drugs | Clean | |
| 26 Aug 2015 – 18 Sep 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Dec 2014 – 3 Dec 2014 | Human Drugs | Clean | |
| 31 Jul 2013 – 14 Aug 2013 | Human Drugs | 483 | On file |
| 25 Jun 2013 – 11 Jul 2013 | Human Drugs | 483 | View 483 → |
| 1 Mar 2013 – 28 Mar 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Sep 2015
21 CFR 812.100
Investigator non-compliance with agreement/plan/regulations
Cited by Peter R Lenahan
Investigators
FDA investigators tied to this site in the record.
Peter R Lenahan2 insp.
Saleem A Akhtar1 insp.
Jogy George1 insp.
Gianine E Tompkins1 insp.
Stephen J Mottola1 insp.
Alberto A Viciedo1 insp.
Christina N Maurino1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 812.100 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ASCENSIA DIABETES CARE US INC.'s 4 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