Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-06.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Mar 2026 – 6 Mar 2026 | Human Drugs | 483 | View 483 → |
| 4 Sep 2025 – 9 Sep 2025 | Human Drugs | Clean | |
| 9 Mar 2023 – 17 Mar 2023 | Human Drugs | 483 | View 483 → |
| 17 Jun 2021 – 2 Jul 2021 | Human Drugs | Clean | |
| 15 Oct 2018 – 30 Oct 2018 | Human Drugs | 483 | On file |
| 19 Mar 2018 – 28 Mar 2018 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Mar 2023
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Bijoy Panicker, Amatul H Marium, Josh Renzo N Ramilo
17 Mar 2023
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Bijoy Panicker, Amatul H Marium, Josh Renzo N Ramilo
17 Mar 2023
21 CFR 211.68(b)
Computer control of master formula records
Cited by Bijoy Panicker, Amatul H Marium, Josh Renzo N Ramilo
17 Mar 2023
21 CFR 211.68(b)
Computer control of master formula records
Cited by Bijoy Panicker, Amatul H Marium, Josh Renzo N Ramilo
Investigators
FDA investigators tied to this site in the record.
Alice S Tsao2 insp.
Emmanuel T Donyina1 insp.
Roberto A Dookhan1 insp.
Bijoy Panicker1 insp.
Amatul H Marium1 insp.
Josh Renzo N Ramilo1 insp.
Gam S Zamil1 insp.
Sony Mathews1 insp.
Marisa R Eschmann1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.89 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Saptalis Pharmaceuticals LLC's 4 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