Overview
- 19 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-20.
At a glance
Inspections
19
Form 483s
11
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Sep 2024 – 20 Sep 2024 | Human Drugs | 483 | On file |
| 13 Mar 2023 – 17 Mar 2023 | Human Drugs | Clean | |
| 15 Aug 2022 – 19 Aug 2022 | Human Drugs | 483 | On file |
| 10 Sep 2019 – 11 Sep 2019 | Human Drugs | Clean | |
| 13 May 2019 – 17 May 2019 | Biologics | 483 | On file |
| 9 Jan 2017 – 17 Jan 2017 | Human Drugs | 483 | On file |
| 12 Jan 2015 – 20 Jan 2015 | Human Drugs | 483 | On file |
| 21 Jul 2014 – 29 Jul 2014 | Human Drugs | Clean | |
| 2 Dec 2013 – 5 Dec 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Nov 2012 | Not recorded | 483 | On file |
| 17 Apr 2012 | Not recorded | 483 | On file |
| 1 Apr 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Thuy T Nguyen1 insp.
Richard Ledwidge1 insp.
Michael Shanks1 insp.
Wayne E Seifert1 insp.
MRA McCulloughJ1 insp.
Prabhu P Raju1 insp.
Mizanne E Lewis1 insp.
Erika V Butler1 insp.
Cynthia Jim1 insp.
Mihaly S Ligmond1 insp.
Robert J Martin1 insp.
Rafael Padilla1 insp.
Sharon K Thoma1 insp.
Steven C Madzo1 insp.
Justin A Boyd1 insp.
Ralph H Vocque1 insp.
Omotunde O Osunsanmi1 insp.
Jose E Melendez1 insp.
Thomas J Arista1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 11 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