Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-03-22.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2019 – 22 Mar 2019 | Biologics | 483 | View 483 → |
| 5 Jan 2015 – 9 Jan 2015 | Human Drugs | 483 | View 483 → |
| 16 Jan 2009 | Not recorded | Clean | |
| 27 Feb 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Leighton K Ngai2 insp.
Patrick D Stone1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.108(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.109(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.109(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 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