Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-01.
At a glance
Inspections
2
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Aug 2023 – 1 Sep 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Oct 2019 – 10 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Sep 2023
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Michelle J Glembin, Mildred J Tures
1 Sep 2023
21 CFR 820.120
Lack of or inadequate procedures for labeling
Cited by Michelle J Glembin, Mildred J Tures
1 Sep 2023
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Michelle J Glembin, Mildred J Tures
1 Sep 2023
21 CFR 820.30(g)
Design validation - Risk analysis
Cited by Michelle J Glembin, Mildred J Tures
1 Sep 2023
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Michelle J Glembin, Mildred J Tures
Investigators
FDA investigators tied to this site in the record.
Michelle J Glembin2 insp.
Mildred J Tures1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind APN Health LLC's 2 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