Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-15.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Apr 2026 – 15 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Jan 2020 – 9 Jan 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Sep 2019 – 26 Sep 2019 | Medical Devices & Rad Health | Clean | |
| 4 Dec 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Apr 2026
ISO 13485:2016 Clause 7.1
Processes needed for product realization not planned and developed
Cited by Marlo-Ian M Alintanahin
15 Apr 2026
ISO 13485:2016 Clause 7.3.10
Design and development files not maintained
Cited by Marlo-Ian M Alintanahin
15 Apr 2026
ISO 13485:2016 Clause 7.5.6
Process for production and service provision not validated
Cited by Marlo-Ian M Alintanahin
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 |
|---|---|---|
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(e) | 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 7.3.10 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Scientific Pharmaceuticals, 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