Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-16.
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 |
|---|---|---|---|
| 13 May 2024 – 16 May 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 May 2022 – 6 May 2022 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 May 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Stephen R Souza, Scott D Stevens
16 May 2024
21 CFR 820.181
DMR - not or inadequately maintained
Cited by Stephen R Souza, Scott D Stevens
16 May 2024
21 CFR 820.184
Lack of or inadequate DHR procedures
Cited by Stephen R Souza, Scott D Stevens
16 May 2024
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Stephen R Souza, Scott D Stevens
16 May 2024
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Stephen R Souza, Scott D Stevens
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 820.50(a)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 830.300(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind TF Health Corp.'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