Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-08-15.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Aug 2023 | Biologics | Clean | |
| 15 Aug 2022 – 18 Aug 2022 | Biologics | 483 | View 483 → |
| 30 Aug 2018 – 31 Aug 2018 | Biologics | Clean | |
| 6 Jun 2016 | Biologics | Clean | |
| 7 Jul 2014 – 8 Jul 2014 | Biologics | Clean | |
| 24 May 2012 | Not recorded | Clean | |
| 11 Mar 2010 | 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.
Brandon L Mariner2 insp.
William D Bassett2 insp.
Carl E Lovrich1 insp.
Leena Thomas1 insp.
Paula J Bretz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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