Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-18.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Oct 2023 – 18 Oct 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 May 2022 – 10 May 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Sep 2017 – 22 Sep 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Sep 2012 | Not recorded | 483 | View 483 → |
| 1 Jun 2011 | Not recorded | 483 | On file |
| 13 Oct 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Oct 2023
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Teresa K Kastner
Investigators
FDA investigators tied to this site in the record.
Teresa K Kastner2 insp.
Maribeth G Grattan2 insp.
Amber M Capello-Jones1 insp.
Christina L Bigham1 insp.
Elizabeth P Kinsella1 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 | 9x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Surgical Appliance Industries Inc's 5 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