Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
5
Form 483s
5
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Feb 2026 – 13 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Sep 2024 – 13 Sep 2024 | Human Drugs | 483 | View 483 → |
| 21 Oct 2021 – 18 Nov 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Feb 2019 – 19 Mar 2019 | Medical Devices & Rad Health | 483 | On file |
| 1 Feb 2017 – 14 Feb 2017 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Feb 2026
21 CFR 830.310(b)
GUDID Information required for unique device identification.
Cited by Frank J Marciniak
13 Feb 2026
21 CFR 830.310(b)
GUDID Information required for unique device identification.
Cited by Frank J Marciniak
13 Feb 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Frank J Marciniak
13 Feb 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Frank J Marciniak
Investigators
FDA investigators tied to this site in the record.
Frank J Marciniak1 insp.
Janet A Rajan1 insp.
Yoriann M Cabrera Bartolomei1 insp.
William R Chang1 insp.
Monika Borkowska1 insp.
Nancy F Scheraga1 insp.
Gobiga Vanniyasingam1 insp.
Russell J Glapion1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 830.310(b) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Accupac, Llc's 5 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