Overview
- 17 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-23.
At a glance
Inspections
17
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Apr 2026 – 23 Apr 2026 | Human Drugs | 483 | On file |
| 18 Feb 2025 – 20 Feb 2025 | Human Drugs | 483 | View 483 → |
| 3 Jun 2024 – 7 Jun 2024 | Human Drugs | 483 | On file |
| 26 Mar 2024 – 29 Mar 2024 | Human Drugs | 483 | On file |
| 21 Nov 2022 – 25 Nov 2022 | Human Drugs | Clean | |
| 18 Nov 2019 – 20 Nov 2019 | Human Drugs | Clean | |
| 16 Sep 2019 – 20 Sep 2019 | Human Drugs | 483 | On file |
| 19 Aug 2019 – 22 Aug 2019 | Human Drugs | Clean | |
| 10 Jul 2017 – 17 Jul 2017 | Human Drugs | Clean | |
| 6 Mar 2017 – 9 Mar 2017 | Human Drugs | Clean | |
| 5 Oct 2016 – 7 Oct 2016 | Human Drugs | Clean | |
| 17 Aug 2016 – 22 Aug 2016 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Kara A Scheibner2 insp.
Sylvestre K Dossou1 insp.
Guerlain Ulysse1 insp.
Dawn C Olenjack1 insp.
Alanna L Mussawwir Bias1 insp.
Farhana Khan1 insp.
Ruben C Ayala1 insp.
Young M Choi1 insp.
Craig A Garmendia1 insp.
Mohsen Rajabi Abhari1 insp.
Arindam Dasgupta1 insp.
Matthew C Watson1 insp.
Tracey L Harris1 insp.
Nicola M Fenty-Stewart1 insp.
Sandra S Saniga1 insp.
Torrance J Slayton1 insp.
Xikui Chen1 insp.
Gulshan R Anand1 insp.
Hector J Colon-Torres1 insp.
Yumi J Hiramine1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 |
| 21 CFR 50.25(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sitec Labs Limited's 7 Form 483s
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