Overview
- 15 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-15.
At a glance
Inspections
15
Form 483s
11
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Mar 2024 – 15 Mar 2024 | Biologics | 483 | View 483 → |
| 12 Sep 2022 – 20 Sep 2022 | Biologics | 483 | On file |
| 27 Jun 2019 – 5 Jul 2019 | Biologics | Clean | |
| 19 Jun 2017 – 27 Jun 2017 | Biologics | 483 | On file |
| 11 May 2015 – 19 May 2015 | Biologics | 483 | On file |
| 20 Jun 2013 – 27 Jun 2013 | Biologics | 483 | On file |
| 22 Jun 2011 | Not recorded | 483 | On file |
| 5 May 2011 | Not recorded | 483 | On file |
| 24 May 2010 | Not recorded | 483 | On file |
| 30 Apr 2009 | Not recorded | 483 | On file |
| 3 Jul 2008 | Not recorded | 483 | On file |
| 1 Apr 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Mar 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Unnee Ranjan, Thai D Truong
Investigators
FDA investigators tied to this site in the record.
Cynthia Jim3 insp.
Christian Lynch3 insp.
Unnee Ranjan2 insp.
Prabhu P Raju2 insp.
Gene D Arcy2 insp.
Thai D Truong1 insp.
Mihaly S Ligmond1 insp.
Steven A Rubin1 insp.
Burnell M Henry1 insp.
Susan M Jackson1 insp.
Qiao Y Bobo1 insp.
Rebecca K Olin1 insp.
Jacqueline M Diaz Albert1 insp.
Paula A Trost1 insp.
Gang Wang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 11 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