Overview
- 14 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-19.
At a glance
Inspections
14
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Mar 2024 – 19 Mar 2024 | Human Drugs | 483 | On file |
| 17 Apr 2023 – 19 Apr 2023 | Medical Devices & Rad Health | Clean | |
| 22 Aug 2022 – 26 Aug 2022 | Human Drugs | 483 | On file |
| 11 Jul 2019 – 17 Jul 2019 | Human Drugs | 483 | On file |
| 4 Jun 2018 – 12 Jun 2018 | Human Drugs | Clean | |
| 5 Feb 2018 – 9 Feb 2018 | Human Drugs | 483 | On file |
| 23 Oct 2017 – 2 Nov 2017 | Biologics | 483 | On file |
| 18 Jul 2016 – 26 Jul 2016 | Human Drugs | Clean | |
| 1 Dec 2014 – 5 Dec 2014 | Human Drugs | 483 | On file |
| 21 Oct 2013 – 28 Oct 2013 | Human Drugs | Clean | |
| 2 Sep 2013 – 5 Sep 2013 | Medical Devices & Rad Health | Clean | |
| 20 Jul 2012 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Dec 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Scott T Ballard, Santos E Camara
Investigators
FDA investigators tied to this site in the record.
Bo Chi1 insp.
Olumide A Martins1 insp.
Shannon A Gregory1 insp.
Wayne E Seifert1 insp.
Michael Shanks1 insp.
Ashley N Queen1 insp.
Stephanie A Slater1 insp.
Thuy T Nguyen1 insp.
Michael R Klapal1 insp.
Simone E Pitts1 insp.
Mihaly S Ligmond1 insp.
Lorie S Hannappel1 insp.
Scott T Ballard1 insp.
Santos E Camara1 insp.
Joey V Quitania1 insp.
Daniel J Lahar1 insp.
Russell K Riley1 insp.
Omotunde O Osunsanmi1 insp.
Thomas J Arista1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 8 Form 483s
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