Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2018-07-12.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jul 2018 – 12 Jul 2018 | Medical Devices & Rad Health | Clean | |
| 18 Jan 2016 – 21 Jan 2016 | Medical Devices & Rad Health | 483 | On file |
| 5 Sep 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jan 2016
21 CFR 803.50(a)(2)
Report of Malfunction
Cited by Amy M Cramer
21 Jan 2016
21 CFR 803.50(a)(2)
Report of Malfunction
Cited by Amy M Cramer
Investigators
FDA investigators tied to this site in the record.
Wanda B Coats1 insp.
Amy M Cramer1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Merit Medical Singapore Pte Ltd's 1 Form 483
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