Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-26.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Mar 2025 – 26 Mar 2025 | Foods & Cosmetics | 483 | View 483 → |
| 19 Aug 2024 – 21 Aug 2024 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Mar 2025
21 CFR 1.511(c)(1)
No CGMPs - supplier approval, performance, risk
Cited by Terris A Mackey
Investigators
FDA investigators tied to this site in the record.
Terris A Mackey1 insp.
Storm Vancuso1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.511(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.502(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.511(c)(2)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.511(c)(5)(i)(A)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.511(c)(5)(i)(B) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Immunotec Research Incorporated's 2 Form 483s
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