Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-15.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Mar 2023 – 15 Mar 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Jan 2020 – 30 Jan 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Feb 2016 – 3 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Oct 2012 | Not recorded | Clean | |
| 23 Feb 2009 | Not recorded | Clean | |
| 14 Mar 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Mar 2023
21 CFR 820.198(b)
Rationale documented for no investigation
Cited by Javonica F Penn, Nisha C Patel
Investigators
FDA investigators tied to this site in the record.
Javonica F Penn1 insp.
Nisha C Patel1 insp.
Shannon A Gregory1 insp.
Cynthia T Cain1 insp.
James G Marsh1 insp.
Allison M Scheck1 insp.
Maribeth G Grattan1 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 | 2x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind APS Materials, Inc.'s 3 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