Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-01.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Apr 2026 – 1 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Dec 2022 – 20 Dec 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Feb 2017 | Medical Devices & Rad Health | Clean | |
| 16 Jul 2013 | Medical Devices & Rad Health | Clean | |
| 4 Mar 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 May 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Albert L Nguyen
1 May 2026
ISO 13485:2016 Clause 6.4.1
Work environment requirements and procedures not documented
Cited by Albert L Nguyen
1 May 2026
ISO 13485:2016 Clause 7.5.7
Sterilization and sterile barrier system validation procedures not documented
Cited by Albert L Nguyen
1 May 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Albert L Nguyen
20 Dec 2022
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Christina L Bigham
Investigators
FDA investigators tied to this site in the record.
Susan M Matthias2 insp.
Albert L Nguyen1 insp.
Christina L Bigham1 insp.
Jennifer S Ness1 insp.
Marissa S Steinhagen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.7 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Access Point Technologies EP, Inc.'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