Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-06-17.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jun 2022 – 17 Jun 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Oct 2019 – 30 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Jun 2016 – 22 Jun 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Mar 2014 – 6 Mar 2014 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jun 2022
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Maida Henesian, Alan L Truong
17 Jun 2022
21 CFR 211.68(b)
Computer control of master formula records
Cited by Maida Henesian, Alan L Truong
30 Oct 2019
21 CFR 812.140(b)(3)
Sponsor records of investigator agreements inadequate
Cited by Kristin M Abaonza
Investigators
FDA investigators tied to this site in the record.
Maida Henesian1 insp.
Alan L Truong1 insp.
Kristin M Abaonza1 insp.
Sergio Chavez1 insp.
Kellia N Hicks1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 812.140(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 812.43(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 812.43(c)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(c) | 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 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Trireme Medical, Inc.'s 3 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