Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-24.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jun 2026 – 24 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Sep 2023 – 19 Sep 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Jul 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 May 2018 – 25 May 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Jun 2016 – 10 Jun 2016 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jun 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Matthew D Schnittker
24 Jun 2026
ISO 13485:2016 Clause 7.3.9
Procedures to control design and development changes not documented
Cited by Matthew D Schnittker
24 Jun 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Matthew D Schnittker
19 Sep 2023
21 CFR 1002.30(a)(2)
Basis for selecting methods, devices, procedures
Cited by Matthew D Schnittker
19 Sep 2023
21 CFR 1002.30(a)(2)
Basis for selecting methods, devices, procedures
Cited by Matthew D Schnittker
Investigators
FDA investigators tied to this site in the record.
Matthew D Schnittker4 insp.
Gamal A Norton1 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 | 6x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1002.30(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1020.30(h)(2)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1020.30(h)(2)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.9 | 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 First Source, 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