Overview
- 16 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-17.
At a glance
Inspections
16
Form 483s
9
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Dec 2025 – 17 Dec 2025 | Human Drugs | 483 | View 483 → |
| 6 Feb 2023 – 13 Feb 2023 | Human Drugs | Clean | |
| 1 Dec 2021 – 7 Dec 2021 | Human Drugs | 483 | View 483 → |
| 5 Apr 2021 – 20 Jul 2021 | Human Drugs | Clean | |
| 1 Oct 2018 – 4 Oct 2018 | Human Drugs | Clean | |
| 11 Jun 2018 – 13 Jun 2018 | Human Drugs | Clean | |
| 6 Jun 2017 – 19 Jun 2017 | Human Drugs | 483 | View 483 → |
| 19 Jan 2016 – 21 Jan 2016 | Human Drugs | Clean | |
| 18 Jun 2015 – 23 Jun 2015 | Human Drugs | Clean | |
| 4 Nov 2014 – 19 Nov 2014 | Human Drugs | 483 | View 483 → |
| 12 Feb 2014 – 20 Mar 2014 | Human Drugs | Clean | |
| 12 Aug 2013 – 13 Aug 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Dec 2021
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Marcellinus D Dordunoo, Daniel J Min
7 Dec 2021
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Marcellinus D Dordunoo, Daniel J Min
7 Dec 2021
21 CFR 211.84(d)(2)
Component identification test
Cited by Marcellinus D Dordunoo, Daniel J Min
7 Dec 2021
21 CFR 211.84(d)(2)
Component identification test
Cited by Marcellinus D Dordunoo, Daniel J Min
Investigators
FDA investigators tied to this site in the record.
Vlada Matusovsky3 insp.
Michael L Casner2 insp.
Marcellinus D Dordunoo2 insp.
Craig D Zagata2 insp.
Matthew R Noonan2 insp.
Maria A Reed2 insp.
Ofuje D Daniyan1 insp.
Daniel J Min1 insp.
Qin Xu1 insp.
Daniel J Deciero1 insp.
Anastasia I Offordile1 insp.
David A Oluwo1 insp.
Christina K Theodorou1 insp.
Gayle S Lawson1 insp.
Luis A Dasta1 insp.
Deborah J Parris1 insp.
Kendra L Brooks1 insp.
Cynthia A Palmer1 insp.
Tiffani D Wilson1 insp.
Hala L Selby1 insp.
Anita R Michael1 insp.
Sam Pepe1 insp.
Margaret E Digennaro1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SigmaPharm Laboratories LLC's 9 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