Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-23.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 23 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Nov 2022 – 9 Nov 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Dec 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Mar 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by William R Chang
23 Mar 2026
ISO 13485:2016 Clause 5.6.1
QMS not reviewed by top management at documented planned intervals
Cited by William R Chang
23 Mar 2026
ISO 13485:2016 Clause 7.4.1
Procedures for purchasing process not documented
Cited by William R Chang
23 Mar 2026
ISO 13485:2016 Clause 7.4.1
Records of supplier (re)evaluation, selection, and monitoring not maintained
Cited by William R Chang
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.6.1 | 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 Pausch LLC'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