Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-12-11.
At a glance
Inspections
6
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Nov 2019 – 11 Dec 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Mar 2018 – 2 May 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Feb 2016 – 27 Jun 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Jan 2015 – 12 Feb 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Sep 2011 | Not recorded | 483 | View 483 → |
| 20 Jan 2010 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Dec 2019
21 CFR 820.198(c)
Investigation of device failures
Cited by Ellen J Tave, Phillip M Pontikos
11 Dec 2019
21 CFR 820.198(c)
Investigation of device failures
Cited by Ellen J Tave, Phillip M Pontikos
11 Dec 2019
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Ellen J Tave, Phillip M Pontikos
Investigators
FDA investigators tied to this site in the record.
Ellen J Tave3 insp.
Andrea A Branche2 insp.
Phillip M Pontikos1 insp.
Jocelyn C Turner1 insp.
Sean T Creighton1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.52(f)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Trilliant Surgical Ltd.'s 6 Form 483s
Source PDFs, 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