Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-18.
At a glance
Inspections
7
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2024 – 18 Sep 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Aug 2021 – 19 Aug 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Jul 2018 – 16 Jul 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Oct 2015 – 12 Nov 2015 | Medical Devices & Rad Health | 483 | On file |
| 8 Sep 2015 – 18 Sep 2015 | Medical Devices & Rad Health | 483 | On file |
| 7 Jan 2014 – 28 Jan 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Dec 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Aug 2021
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Kevin N Tran, Alexandria L Capuano
Investigators
FDA investigators tied to this site in the record.
Kevin N Tran2 insp.
Alexandria L Capuano1 insp.
Sean T Creighton1 insp.
Scott K Zika1 insp.
Charles L Larson1 insp.
Kimberly M Lichter1 insp.
Trudy R Papson1 insp.
Kirtida Patel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Apnea Sciences Corporation's 7 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