Overview
- 28 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-08.
At a glance
Inspections
28
Form 483s
13
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Mar 2026 – 8 Apr 2026 | Human Drugs | 483 | On file |
| 9 Feb 2026 – 11 Feb 2026 | Biologics | Clean | |
| 2 Oct 2023 – 13 Oct 2023 | Human Drugs | Clean | |
| 6 Sep 2023 – 19 Sep 2023 | Biologics | 483 | On file |
| 19 Jul 2021 – 23 Jul 2021 | Biologics | 483 | On file |
| 29 Apr 2019 – 3 May 2019 | Human Drugs | 483 | On file |
| 14 Jan 2019 – 18 Jan 2019 | Human Drugs | 483 | On file |
| 4 Jan 2019 – 17 Jan 2019 | Human Drugs | 483 | On file |
| 11 Dec 2017 – 15 Dec 2017 | Human Drugs | Clean | |
| 6 Oct 2017 – 12 Oct 2017 | Human Drugs | Clean | |
| 17 Apr 2017 – 28 Apr 2017 | Biologics | 483 | On file |
| 14 Sep 2016 – 30 Sep 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jan 2019
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Sean R Marcsisin, Jee Y Chung
17 Jan 2019
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Sean R Marcsisin, Jee Y Chung
17 Jan 2019
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Sean R Marcsisin, Jee Y Chung
17 Jan 2019
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Sean R Marcsisin, Jee Y Chung
Investigators
FDA investigators tied to this site in the record.
Debra M Emerson4 insp.
Sean R Marcsisin2 insp.
Erik W Koester1 insp.
Syeda N Mahazabin1 insp.
Matthew C Watson1 insp.
Robert J Martin1 insp.
Ogechi C Nna1 insp.
Gene D Arcy1 insp.
Brentley S Collins1 insp.
Priscilla M Pastrana1 insp.
Brentley S Pittman1 insp.
Kathleen R Jones1 insp.
Anissa M Cheung1 insp.
Ekaterina Allen1 insp.
Amy A Devlin1 insp.
Maxwell L Van Tassell1 insp.
Jee Y Chung1 insp.
Kara A Scheibner1 insp.
Yanming An1 insp.
Christopher D Downey1 insp.
Stacey S Degarmo1 insp.
Wayne E Seifert1 insp.
Christina A Capacci-Daniel1 insp.
Zhihao Pete Qiu1 insp.
Arie Menachem1 insp.
Burnell M Henry1 insp.
Christian Lynch1 insp.
Paula A Trost1 insp.
Joyce A Rockwell1 insp.
Martha T Olone1 insp.
Justine M Corson1 insp.
Dawn M Braswell1 insp.
Brenda P King1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 4x |
Full site report
Get the verbatim findings behind this site's 13 Form 483s
Source PDFs 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