Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-02-12.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Feb 2026 – 12 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Feb 2020 – 5 Feb 2020 | Medical Devices & Rad Health | Clean | |
| 4 Dec 2017 – 5 Dec 2017 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Feb 2026
ISO 13485:2016 Clause 8.2.1
Feedback process procedures not documented
Cited by Linda Galindo
12 Feb 2026
ISO 13485:2016 Clause 8.4
Analysis of data not used as input for QMS improvement where necessary
Cited by Linda Galindo
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 |
|---|---|---|
| ISO 13485:2016 Clause 8.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.4 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Therapak Corporation's 1 Form 483
Source PDFs 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