Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-04-22.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Mar 2015 – 22 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Mar 2014 – 7 May 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Feb 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
7 May 2014
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Frank J Marciniak
7 May 2014
21 CFR 820.30(g)
Design validation - user needs and intended uses
Cited by Frank J Marciniak
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(a) | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Therakos, 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