Overview
- 13 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-19.
At a glance
Inspections
13
Form 483s
6
EIRs
5
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Dec 2025 – 19 Dec 2025 | Human Drugs | Clean | |
| 14 Feb 2024 – 20 Feb 2024 | Human Drugs | Clean | |
| 17 Apr 2023 – 21 Apr 2023 | Human Drugs | 483 | On file |
| 29 Aug 2022 – 2 Sep 2022 | Human Drugs | 483 | View 483 → |
| 3 Dec 2021 – 20 Dec 2021 | Human Drugs | 483 | View 483 → |
| 10 Jun 2019 – 21 Jun 2019 | Human Drugs | 483 | View 483 → |
| 16 Apr 2018 – 20 Apr 2018 | Human Drugs | Clean | |
| 12 Mar 2018 – 16 Mar 2018 | Human Drugs | Clean | |
| 12 Mar 2018 – 14 Mar 2018 | Human Drugs | Clean | |
| 29 Dec 2014 – 9 Jan 2015 | Human Drugs | 483 | View 483 → |
| 10 Sep 2013 – 18 Sep 2013 | Human Drugs | Clean | |
| 26 Mar 2013 – 2 Apr 2013 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Sep 2022
21 CFR 211.67(b)
Written procedures fail to include
Cited by Mindy M Chou, Sayyem H Akbar, Karishma G Gopaul
2 Sep 2022
21 CFR 211.67(b)
Written procedures fail to include
Cited by Mindy M Chou, Sayyem H Akbar, Karishma G Gopaul
2 Sep 2022
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Mindy M Chou, Sayyem H Akbar, Karishma G Gopaul
2 Sep 2022
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Mindy M Chou, Sayyem H Akbar, Karishma G Gopaul
Investigators
FDA investigators tied to this site in the record.
Robert C Horan4 insp.
Roberto A Dookhan1 insp.
Amatul H Marium1 insp.
Xikui Chen1 insp.
Mindy M Chou1 insp.
Sayyem H Akbar1 insp.
Karishma G Gopaul1 insp.
Gam S Zamil1 insp.
Vivin George1 insp.
Lata C Mathew1 insp.
Jogy George1 insp.
Alice S Tsao1 insp.
Bijoy Panicker1 insp.
Tara K Carmody1 insp.
Neil J Bonzagni1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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 Sciegen Pharmaceuticals Inc's 6 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