Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2015-09-08.
At a glance
Inspections
4
Form 483s
1
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Aug 2015 – 8 Sep 2015 | Medical Devices & Rad Health | Clean | |
| 10 Mar 2014 – 16 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Sep 2013 – 11 Sep 2013 | Medical Devices & Rad Health | Clean | |
| 23 Mar 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Apr 2014
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Lauren L Vajo, Kristen E Rescigno
16 Apr 2014
21 CFR 803.50(b)(1)
Reporting Information Reasonably Known
Cited by Lauren L Vajo, Kristen E Rescigno
16 Apr 2014
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Lauren L Vajo, Kristen E Rescigno
Investigators
FDA investigators tied to this site in the record.
Gamal A Norton1 insp.
Lauren L Vajo1 insp.
Kristen E Rescigno1 insp.
Babatunde D Babalola1 insp.
Michelle D Haamid1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | 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 ConvaTec'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