Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-09.
At a glance
Inspections
6
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Aug 2024 – 9 Aug 2024 | Human Drugs | 483 | View 483 → |
| 23 May 2016 – 27 May 2016 | Human Drugs | 483 | View 483 → |
| 17 Feb 2012 | Not recorded | 483 | On file |
| 26 Aug 2011 | Not recorded | 483 | On file |
| 11 Jun 2007 | Not recorded | Clean | |
| 12 Mar 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Aug 2024
21 CFR 58.190(c)
Archives: individual responsible
Cited by Kristin M Abaonza, Erin M Mcdowell
27 May 2016
21 CFR 58.47(a)(3)
Facility: article mixture storage areas
Cited by Stuart W Russell, Abhijit Raha
Investigators
FDA investigators tied to this site in the record.
Stuart W Russell2 insp.
Kristin M Abaonza1 insp.
Erin M Mcdowell1 insp.
Abhijit Raha1 insp.
Jennifer H Rhyu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.190(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.47(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.63(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.190(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SRI International's 4 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